Surgical incision and closure apparatus

ABSTRACT

An apparatus for closing a surgical incision comprises left and right base panels, a plurality of closure components, and a plurality of left and right axial supports coupled to the respective base panels. The closure components couple the left and right base panels to each other laterally and have left and right ends coupled to the respective base panels. The closure components are positioned laterally across the left and right panels, the left axial supports are disposed between pairs of left closure component ends, the right axial supports are disposed between pairs of right closure component ends, and the left and right axial supports are offset from one another such that a serpentine arrangement of consecutive closure components and axial supports is formed. The apparatus can be made of antimicrobial materials or materials impregnated with antimicrobial agents. A flexible adhesive cover can be provided over the apparatus when in use.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/625,366 (Attorney Docket No. 35383-709.301), filed Feb. 18, 2015,which is a continuation of U.S. patent application Ser. No. 14/180,564(Attorney Docket No. 35383-709.502), now U.S. Pat. No. 9,089,328, filedFeb. 14, 2014, which is a continuation-in-part of U.S. patentapplication Ser. No. 13/665,160 (Attorney Docket No. 35383-709.501),filed Oct. 31, 2013, which is a continuation-in-part of U.S. patentapplication Ser. No. 13/286,757 (Attorney Docket No. 35383-709.201), nowU.S. Pat. No. 8,323,313, filed Nov. 1, 2011, and also claims the benefitof U.S. Provisional Applications Nos. 61/889,569 (Attorney Docket No.35383-712.101), filed Oct. 11, 2013, 61/958,259 (Attorney Docket No.35383-710.101), filed Jul. 24, 2013, and 61/958,254 (Attorney Docket No.35383-711.101), filed Jul. 24, 2013, the full disclosures of which areincorporated herein by reference.

The subject matter of this application is related to co-pending U.S.patent application Ser. No. 14/180,524 (Attorney Docket No.35383-712.201), filed Feb. 14, 2014, the full disclosures of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical apparatus andmethods. More particularly, present invention relates to apparatus andmethods for forming and closing surgical incisions.

Surgical closure devices including an adhesive based patch with rightand left panels are known. Of particular interest of the presentinvention, such devices are described in co-pending, commonly owned PCTapplication US 2010/000430, full disclosure which is incorporated hereinby reference. As described in the PCT application, an adhesive patch isplaced over a patient's skin at a site where it is desired to form asurgical incision. After the patch is placed, an incision is formedalong an axial line extending through the middle of the patch. After itis formed, the incision can be opened to perform a desired procedure,and after the procedure is completed the incision may be closed bydrawing the inner edges of the panels together with a clip, zipper, orother closure member.

The principal objective of such surgical closure devices is to improvehealing and reduce scarring from the incision. This objective, however,has been inhibited by certain characteristics of the presently availabledevices. For example, the tissue edges are not always brought togetheralong a line evenly, which can increase the eventual scarring. Many suchclosure devices do not have the ability to adjust the closure force ordistance on the tissue edges, limiting the ability to slightly “pucker”tissue which has been found to reduce scarring. Other shortcomings ofthe available incision and wound closure devices include difficulty ofuse and inability to conform to tissue manipulation during subsequentsurgical protocols, i.e. those devices which are sufficiently rigid tosecurely close the tissue are often unable to conform to the tissuemovement during the surgical procedure.

A particular problem arises with self-adhesive wound closure patcheswhen they're used beneath an adherent surgical incision drape. Suchdrapes are used to help maintain the sterility of a tissue surfaceduring a surgical procedure, and the drapes may be placed over apreviously positioned tissue closure patch. As the surgical incisiondrape has an adhesive lower surface which adheres to the tissue, thedrape will adhere to an upper surface of an underlying tissue closurepatch. Removal of the surgical incision drape will thus often remove orat least displace a previously placed tissue closure patch. If anysignificant portion of the tissue closure patch is removed or displaced,the patch will no longer be useful for closing a surgical wound.

For these reasons, it would be desirable to provide improved surgicalincision closure devices and methods for their use. It would beparticularly desirable to provide incision closure devices which areable to adhere to the tissue, allow formation of the incision, conformto the deformation of the tissue during a subsequent surgical procedure,and provide controlled closure of the adjacent tissue edges subsequentto the procedure. In particular, it would be desirable if the incisionclosure devices were able to provide for the control and the uniformdistribution of closure forces on the tissue edges while causing minimumrestraint or stretching of the tissue during the surgical procedure. Itwould be still further desirable to provide improved surgical incisionclosure devices and methods for their use where the devices will resistremoval and dislocation when used beneath a surgical incision drape. Atleast some of these objectives will be met by the inventions describedbelow.

2. Description of the Background Art

Surgical closure devices are described in U.S. Pat. Nos. 2,012,755;3,516,409; 3,863,640; 3,933,158; 4,114,624; 3,926,193; 4,535,772;4,676,245; 4,881,546; 4,905,694; 5,377,695; and 7,455,681; and U.S.Patent Publication Nos. 2005/0020956 and 2008/0114396. Further surgicalclosure devices are described in commonly owned U.S. Pat. Nos.8,313,508, 8,323,313, and 8,439,945; U.S. Patent Publication No.2013/0066365; and PCT Publication nos. WO 2011/139912, WO 2011/159623,WO 2011/043786, and WO 2013/067024, the full disclosures of which areincorporated herein by reference. Commercial incision closure devicesavailable from Ethicon, a division of Johnson & Johnson, under the tradename Ethizip™ temporary abdominal wound closure device.

SUMMARY OF THE INVENTION

The present invention provides improved apparatus and methods forclosing wounds, particularly wounds resulting from incisions performedduring surgical procedures. The incisions would usually be formed in apatient's skin, such as through the abdomen, but in some cases couldalso be on internal organs, within the oral cavity, within bodycavities, or alike.

The devices and methods of the present invention will present minimumdisruption of or interference with the surgical procedure which isperformed after the incision is made. In particular, the devices andmethods will permit the opposed edges of the incised tissue to beopened, stretched, and freely deformed with minimal restraint resultingfrom the presence of the closure device. Once the procedure has beencompleted, however, the devices and methods of the present inventionwill provide for a uniform distribution of closure forces to draw thetissue edges together in a manner which minimizes scarring. Inparticular, the closure devices can draw the tissue edges together at aslightly closer spacing than initially present at the forming of theincision in order to upwardly evert the tissue edges and cause a“pucker” which can reduce scarring.

The devices and methods of the present invention will also be able toavoid or reduce disruption when an incision closure appliance is usedbeneath surgical incision drape which must be removed from over theclosure appliance. A sacrificial layer is provided over at least part ofthe upper surface of the closure appliance, where the sacrificial coveris held in place while the surgical incision drape is placed over theincision closure appliance. After the incision and surgical procedurehave been completed, the surgical incision drape will be pulled from thepatient's skin. Instead of adhering to and dislodging the tissue closureappliance, the surgical drape adheres to the sacrificial cover, and onlythe sacrificial cover is pulled from the patient with the drape, leavingthe remainder of the incision closure appliance in place.

In a first aspect of the present invention, an incision closureappliance comprises a base including a left panel and a right panel.Each panel has a tissue adherent lower surface, an upper surface, aninner edge, and an outer edge. The lower tissue adherent surface willtypically be coated at least partially with a common tissue-adherentadhesive such as those used in surgical bandages and patches.

The incision closure appliance further includes a force distributionstructure coupled to each panel (i.e. each panel will have at least oneforce distribution structure coupled thereto), where each forcedistribution structure is adapted to allow axial expansion of the panelalong the inner edge while limiting lateral expansion over the entirelength and axial expansion along the outer edge. By permitting axialexpansion of the panel along the inner edge, the tissue edges areminimally constrained to allow the tissue to deform when stretchedduring the surgical procedure. Conversely, by limiting both lateralexpansion and axial expansion along the outer edge, the panel will beable to apply a controlled and distributed closure force when the panelsare drawn together after the surgical procedure is complete, asdescribed in more detail below.

The incision closure appliance still further includes a closurecomponent or assembly which attaches to the force distribution structureto draw the inner edges of the panels together after they had beenadhered to the tissue on opposite sides of an incision site and thesurgical procedure completed. Each panel of the base will typicallycomprise an at least partially elastic matrix, typically having anisotropic elasticity (i.e. the panel stretches evenly in all directions)but optionally having an anisotropic elasticity (where the matrixstretches preferentially in one direction or over a portion thereof).The elastic matrix may comprise an elastomeric membrane or sheet (forexample Polyurethane sheet or Thermo Plastic Elastomers (TPE)), a wovenfabric (typically woven at least partially from elastomeric filaments,threads, or fibers), a spun fabric, or the like. In certain embodiments,the elastomeric matrix may comprise a fabric woven from both elasticelements (typically threads, filaments, fibers, or the like) and havinginelastic elements disposed along the outer edge and extending laterallythere across in order to provide the expansion characteristics describedabove with respect to the force distribution structure. That is, in somecases, the force distribution structure may include or consist ofinelastic elements woven or otherwise incorporated within a fabricmembrane.

Typically, the force distribution structure will comprise a separatecomponent of the incision closure appliance, for example including aspine disposed axially adjacent to the outer edge of the panel and aplurality of axially spaced-apart lateral supports disposed laterallyand extending from the spine toward the inner edge of the panel. Such a“comb-like” structure will typically be formed from flexible butnon-distensible materials so that the elements can flex together withthe tissue deformation but will not stretch along their lengths so thatthey may provide dimensional stability in the lateral direction as wellas along the outer edge of the panel. Examples of such materials includeNylon, Polypropylene, Polyethylene and Polycarbonate or otherthermoplastic polymers. Notably, the force distribution structure willnot limit the axial stretching of the inner edge of the panel in orderto provide the desired expansibility and conformability to the tissueduring the surgical procedure. Such separate force distributionstructures may be attached to the upper surface of the panel, oralternatively may be embedded in or laminated within the panel.Typically, the force distribution structure will not extend into or pastthe lower surface of the panel so that it will not interfere withadherence of the panel to the skin or other tissue.

The assembly of the base panels and the force distribution structureswill typically be carried on a removable backing which covers andprotects the adherent surface of the panels prior to use. The backingmay be removed in order to apply the base to the skin or other tissue atthe site of the surgical intervention. Additionally, the right and leftpanels will typically be held together by removable tabs, an axialstrip, or other removable covers or structures in order to hold theinner edges of the panel at a pre-determined distance or spacing as theyare being adhered to the tissue. For example, removable tabs may beplaced at each axial end of the base to temporarily secure the two basepanels together. Alternatively, a removable strip or tape may be placedover an axial gap between the right and left panels to hold the panelsin place relative to each other as the base is being adhered to thetissue surface. Such tabs or strips will typically be self-adhesive sothat they may be secured to the panels and then removed by simplypulling off after the panels are properly placed on the tissue. Thecover, tabs, or strip may then be removed to leave the panels in placebut unconnected prior to forming the surgical incision therebetween.

A first exemplary construction of the closure component or assemblycomprises a right engagement member, a left engagement member, and aplurality of lateral struts holding the engagement members laterallyapart by a pre-determined distance. The right engagement member isadapted to releasably engage the supports of the right panel along aninner edge thereof, and the left engagement member is adapted toreleasably engage the supports of the left panel along an inner edgethereof. In the specific embodiments, at least some of the supports ofthe force distribution component will have cleats near their inneredges, and the engagement members will have slots which receive thecleats. After the surgical intervention is complete, the closurecomponent may then be placed over the force distribution structure withthe cleats on one side first being engaged by an engagement member andthen the opposite engagement member being pulled over the cleats on theopposite side.

Alternatively, the closure component or assembly may comprise aplurality of independent lateral ties attached to at least some of thelateral supports. Such lateral ties are configured to be secured betweenthe lateral supports, typically being fixed to one panel and beingadjustably attachable to the other panel. For the exemplary embodiments,the adjustably attachable end may comprise a ratchet tighteningmechanism or similar structure which allows each lateral tie to beindependently adjusted at a different spacing between the right and leftpanels. In this way, the right and left panels may be differentiallytensioned along their inner edges in order to control and optimize theforces applied to the adjacent tissue edges which are being drawntogether.

Optionally, the closure appliance of the present invention may furthercomprise a securing layer which is adapted to be placed over theassembly of the base and the closure component after the assembly hasbeen secured over an incision on a patient's skin and the surgicalprocedure has been completed. A securing layer will typically have aself-adhesive lower surface which can be placed over the assembly of thebase and closure component to help secure it in place and to maintaincleanliness. The securing layer may optionally have openings to permitaccess to the wound for observation, delivery of antiseptics, and thelike.

In a further aspect of the present invention, methods for forming anincision in tissue comprise providing an incision closure appliance asdescribed above. The right and left panels of the appliance are adheredto the patient's skin, where the inner edges of the panels arespaced-apart by a pre-selected distance typically from 0.5 mm to 15 mm.An incision (typically linear) is formed in the tissue or skin surfacebetween the inner edges of the panels, and the edges of the incisedtissue are then separated to perform a desired surgical procedure. Theinner edges of the panels can stretch and conform along with movementand deformation of the tissue edges while the outer edge and lateralextent of each panel remain dimensionally stable. After the procedure iscomplete, the closure component is secured to the force distributionstructure to draw the inner edges of the panels back together.Optionally, the closure component has dimensions (or an adjustableinter-panel spacing) which draw the tissue edges closer together thanthey were immediately after the incision was formed. Such drawingtogether of the tissue causes the edges to evert and the tissue to“pucker” which can reduce scarring.

In yet a further aspect of the present invention, an incision closureappliance is provided. The incision closure appliance may comprise leftand right base panels, a plurality of closure components for couplingthe left and right base panels to each other laterally, and a pluralityof left and right axial supports coupled, respectively, to the left andright base panels. Each closure component comprises left and rightclosure component ends coupled, respectively, to the left and right basepanels. The plurality of closure components may be positioned laterallyacross the left and right panels with (i) one or more of the left axialsupports disposed between at least some axially adjacent left closurecomponent ends and (ii) one or more of the right axial supports disposedbetween at least some axially adjacent right closure component ends toform a serpentine arrangement.

To form the serpentine arrangement, a left axial support couples everyother axially adjacent pair of left closure component ends together onthe left panel and/or a right axial support couples every other axiallyadjacent pair of right closure component ends together on the rightpanel. The left and/or right panels may have one or more perforationsdisposed between axially adjacent the respective left and/or rightclosure component ends having no axial support disposed therebetween.The one or more perforations may comprise a plurality of perforationsthat facilitate the separation of the base panel into base panelsegments upon axial stretching of the base panel.

One or more of the left or right base panels may comprise a plurality ofseparate base panel segments. At least two left closure component endsor at least two right closure component ends may be coupled to each basepanel segment. The left base panel may comprise a plurality of left basepanel segments, and the right base panel may comprise a plurality ofright base panel segments. The left base panel segments and the rightbase panel segments may be axially offset from one another when appliedto an incision and surrounding tissue. The plurality of closurecomponents may couple the left and right base panel segments to eachother laterally to form the serpentine arrangement.

One or more of the left or right base panels may comprise a tissueadherent lower surface for adhering to the tissue adjacent the incision.One or more of the left or right base panels may comprise a loweradhesive layer comprising the tissue adherent lower surface and an upperlayer comprising an upper surface. The upper layer may be more rigidthan the lower adhesive layer. The lower adhesive layer may besufficiently elastic such that blistering and adhesion loss due tomovement of tissue laterally adjacent the incision closure device whencovering the incision and surrounding tissue are minimized. The adhesivelower layer may comprise a hydrophilic adhesive material. Thehydrophilic adhesive material may comprise one or more of ahydrocolloid, a hydrogel, an acrylic polymer, or poly (ethylene glycol).The upper layer may comprise one or more of rubber, latex, urethane,polyurethane, silicone, a thermo plastic elastomer (TPE), a wovenfabric, or a spun fabric. One or more of the left closure componentends, right closure component ends, left axial supports, or right axialsupports may be embedded in or laminated to the upper surfaces of theleft and right base panels.

One or more of the left closure component ends, right closure componentends, left axial supports, or right axial supports may be formed fromflexible, non-distensible materials.

The plurality of closure component, left axial supports, and right axialsupports may together be sufficiently rigid such that movement of tissuelaterally adjacent the incision closure device when covering an incisionand surrounding tissue does not substantially distend the coveredincision and surrounding tissue. Accordingly, movement of a first tissueregion laterally adjacent a periphery of the incision closure device maysubstantially translate into a same movement of a second tissue regionlaterally adjacent the periphery and opposite the first tissue region.

One or more closure component of the plurality of closure components maycomprise a tie securely coupled to the left or right closure componentend and adjustably attached to the opposite closure component end. Theopposite closure component end may comprise a ratchet tighteningmechanism.

The plurality of closure components may be configured to draw inneredges of the left and right base panels together to compress an incisioncovered by the incision closure appliance.

One or more of the plurality of left axial supports or the plurality ofright axial support may be C-shaped. The C-shaped left and/or rightaxial supports may each comprise an axial portion for limiting axialexpansion of the respective base panel and a lateral portion forlimiting lateral expansion of the respective base panel.

This aspect of the present invention may also provide a system forclosing an incision in tissue. The system may comprise the incisionclosure device and a flexible cover for overlying the incision closuredevice and the covered incision and surrounding tissue.

The flexible cover may be configured to extend over lateral and axialedges of the left and right base panels. The cover may have one or moreperforations to allow the cover to at least partially stretch axially inresponse to axial stretching of the incision and surrounding tissuecovered by the incision closure device. The one or more perforations maybe disposed along a central axial line of the cover. The cover maycomprise one or more reinforcing members coupled to at least a portionof an adhesive layer of the cover. The reinforcing members may compriseone or more of rubber, latex, urethane, polyurethane, silicone, a thermoplastic elastomer (TPE), a woven fabric, or a spun fabric. The cover maycomprise a hydrophilic adhesive layer which may comprise one or more ofa hydrocolloid, a hydrogel, an acrylic polymer, or poly (ethyleneglycol).

In yet a further aspect of the present invention, an incision closureappliance is provided. The incision closure appliance comprises aflexible adhesive bottom layer, a middle layer, and a top layer. Theflexible adhesive bottom layer may have a first elasticity. The middlelayer may be coupled to and cover at least a portion of the flexibleadhesive layer and have a second elasticity less than the firstelasticity. The top layer may be coupled to and cover at least a portionof the middle layer and have a third elasticity less than the secondelasticity. An elasticity gradient between the flexible adhesive bottomlayer and the top layer may provide sufficient stiffness for theincision closure appliance such that movement of tissue laterallyadjacent the appliance when covering an incision and surrounding tissuedoes not substantially distend the covered incision and surroundingtissue.

The elasticity gradient may provide sufficient elasticity for theincision closure appliance such that blistering and adhesion loss due tomovement of tissue adjacent the appliance when covering the incision andsurrounding tissue are minimized.

The incision closure appliance may be axially flexible in response toaxial stretching of the incision and surrounding tissue covered by theincision closure appliance. Movement of a first tissue region adjacentthe periphery of the flexible adhesive bottom layer may substantiallytranslates into a same movement of a second tissue region adjacent theperiphery of the flexible adhesive bottom layer and opposite the firsttissue region.

The flexible adhesive bottom layer may comprise a hydrophilic adhesivematerial. The hydrophilic adhesive material may comprise one or more ofa hydrocolloid, a hydrogel, an acrylic polymer, or poly (ethyleneglycol).

The upper layer may comprise one or more of rubber, latex, urethane,polyurethane, silicone, a thermo plastic elastomer (TPE), a wovenfabric, or a spun fabric.

The flexible adhesive bottom layer may comprise first and secondadhesive bottom layers. The middle layer may comprise a first upperlayer coupled to the first adhesive bottom layer and a second upperlayer coupled to the second adhesive bottom layer. The top layer maycomprise an arrangement of a plurality of axial support structures and aplurality of lateral closure components coupled to the axial supportstructures for fastening the first adhesive bottom layer and the firstupper layer to the second adhesive bottom layer and the second upperlayer. The plurality of axial support structures and the plurality ofclosure components may be coupled to one another to form a serpentinepattern for allowing the one or more of the lower adhesive layer or themiddle layer to at least partially stretch in the axial direction of theclosure device in response to axial stretching of the incision andsurrounding tissue covered by the incision closure device. The pluralityof axial support structures and the plurality of lateral closurecomponents may be coupled to one another to form a ladder pattern. Oneor more of the plurality of axial support structures or the plurality oflateral closure components may be formed from flexible, non-distensiblematerials. The plurality of lateral closure components may be configuredto draw inner edges of one or more of the first or second adhesivebottom layers and the first or second upper layers together afterflexible adhesive bottom layer is adhered to tissue on opposite sides ofthe incision. One or more of the lateral closure components may comprisea left end, a right end, and a tie securely coupled to the left or rightend and adjustably attached to the opposite end. One or more of theplurality of axial support structures or the plurality of lateralclosure components may be embedded in or laminated to the first andsecond upper layers.

This aspect of the present invention may also provide a system forclosing an incision in tissue. The system comprises the incision closureappliance and a flexible cover for overlying the incision closureappliance and the covered incision and surrounding tissue.

The flexible cover may be configured to extend over lateral and axialedges of the flexible adhesive bottom layer. The cover may have one ormore perforations to allow the cover to at least partially stretch inthe axial direction of the cover in response to axial stretching of theincision and surrounding tissue covered by the incision closureappliance. The one or more perforations may be disposed along a centralaxial line of the cover. The cover may comprise one or more reinforcingmembers coupled to at least a portion of an adhesive layer of the cover.The reinforcing members may comprise one or more of rubber, latex,urethane, polyurethane, silicone, a thermo plastic elastomer (TPE), awoven fabric, or a spun fabric. The cover may comprise a hydrophilicadhesive layer. The hydrophilic adhesive layer may comprise one or moreof a hydrocolloid, a hydrogel, an acrylic polymer, or poly (ethyleneglycol).

In yet a further aspect of the present invention, an incision closureappliance is provided. The incision closure appliance may comprise alower portion having a first elasticity, an upper portion having asecond elasticity less than the first elasticity, and an elasticitygradient between the lower portion and the upper portion. The elasticitygradient may provide sufficient stiffness for the incision closureappliance such that movement of tissue laterally adjacent the appliancewhen covering an incision and surrounding tissue does not substantiallydistend the covered incision and surrounding tissue. The elasticitygradient may provide sufficient elasticity for the incision closureappliance such that blistering and adhesion loss to due to movement oftissue laterally adjacent the appliance when covering an incision andsurrounding tissue is minimized.

In yet a further aspect of the present invention, an incision closureappliance is provided. The incision closure appliance may comprise abase including a left panel and a right panel, left and right forcedistribution structures, and a plurality of closure components. Eachpanel may have a tissue adherent lower surface, an upper surface, afirst lateral edge, a second lateral edge. The left and right forcedistribution structures may be coupled to the left and right panels,respectively. Each force distribution structure may be adapted to allowaxial expansion of the panel along one of the first or second lateraledges and to limit lateral expansion across the panel and axialexpansion along the opposite lateral edge. The plurality of closurecomponents may be secured to the left and right panels to draw thepanels together after the panels are adhered to tissue and an incisionmade therebetween.

The first lateral edges of each panel may comprise inner edges of eachpanel. The inner edges of each panel may face toward one another.

The second lateral edges of each panel may comprise outer edges of eachpanel. The outer edges of each panel may face away from one another.

One or more of the left and right panels of the base may comprise anelastic matrix. The elastic matrix may comprise an elastomeric membrane,a woven fabric, or a spun fabric. The elastic matrix may comprise afabric woven from elastic elements and having inelastic elements alongthe first or second lateral edge and extending laterally thereacross.

Each force distribution structure may comprise a spine disposed axiallyadjacent to the first lateral edge of the panel and a plurality ofaxially spaced-apart lateral supports disposed laterally and extendingfrom the spine toward the first lateral edge of the panel. The spine andlateral supports may be formed from flexible, non-distensible materials.The force distribution structures may be embedded in or laminated to theupper surface of each panel.

The closure component may comprise a right engagement member, a leftengagement member and a plurality of lateral struts holding theengagement members laterally spaced apart by a predefined distance. Theright engagement member may be adapted to releasably engage the supportsof the right panel and the left engagement member may be adapted toreleasably engage the supports of the left panel. At least some of thesupports may have cleats near the one or more of the first or secondlateral edges and the engagement members may have slots which receivethe cleats. The lateral struts may be adjustably connected to at leastone of the engagement members to permit adjustment of the predefineddistance. The closure component may comprise a plurality of independentlateral ties attached to at least some of the lateral supports. Thelateral ties may be configured to be secured between lateral supports.The independent lateral ties may each have one end fixed to a panel anda second end adjustably attached to the other panel. The second end maycomprise a ratchet tightening mechanism.

The incision closure appliance may further comprise a securing layeradapted to be placed over an assembly of the base and the closurecomponents after the assembly has been secured over an incision on apatient's skin. The securing layer may have an inner self-adhesivesurface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of an incision closure appliance constructedin accordance with the principles of the present invention.

FIG. 2 is a top view of the assembly of a base and a force distributionstructure which is part of the incision closure appliance.

FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 2.

FIGS. 4-7 illustrate use of the incision closure appliance of thepresent invention for forming and closing an incision in a patient'sskin.

FIG. 8 illustrates an alternative construction of a closure componentfor the closure appliance of the present invention.

FIG. 9 is an exploded view of a further embodiment of an incisionclosure appliance constructed in accordance with the principles of thepresent invention.

FIG. 10 is an enlarged isometric view of the base and force distributionstructure of the system of FIG. 9.

FIGS. 11A and 11B illustrate an alternative lateral tie constructionwhich can be used in the appliances of either FIG. 1 or FIG. 9.

FIG. 12 illustrates a sacrificial cover positioned over an incisionclosure appliance in accordance with the principles of the presentinvention.

FIGS. 13A through 13E illustrate the principle of operation of thesacrificial cover illustrated in FIG. 12 when used together with asurgical incision drape and performing methods according to the presentinvention.

FIGS. 14A1-14A3 are perspective views of further embodiments of anincision closure appliance constructed in accordance with the principlesof the present invention.

FIG. 14B is a top view of an incision closure appliance similar to thatof FIGS. 14A-14A3 and which is placed on the knee of a subject accordingto the present invention.

FIG. 15A shows a schematic of an incision closure appliance having apulley system to laterally couple two adjacent base panels in accordancewith the principles of the present invention;

FIG. 15B shows a sectional view of the incision closure appliance ofFIG. 15A.

FIG. 15C shows the incision closure appliance of FIG. 15A placed on amodel knee according to the present invention.

FIG. 15D shows a schematic of an incision closure appliance similar tothat of FIG. 15A.

FIGS. 15E and 15F show various lateral tie assembly structures for usewith the incision closure appliance of FIGS. 15A and 15D, respectively.

FIGS. 16A-16D show various locking mechanisms in accordance with theprinciples of the present invention.

FIG. 17 shows a hinging mechanism for incision closure appliances inaccordance with the principles of the present invention.

FIG. 18 is a top view of an incision closure appliance similar to thatof FIG. 14A and placed on the knee of a subject according to the presentinvention.

FIG. 19 shows an incision closure appliance comprising individual pairsof base panel segments according to the present invention.

FIG. 20A shows a perspective view of the incision closure appliancesimilar to that of FIGS. 9 and 10 in accordance with the principles ofthe present invention.

FIG. 20B shows a magnified view of the lateral tie assembly of theincision closure appliance of FIG. 20A.

FIG. 21 shows an exploded view of a portion of the incision closureappliance of FIG. 21.

FIG. 22A shows a perspective view of a cover for the incision closureappliances disclosed herein in accordance with the principles of thepresent invention.

FIG. 22B shows an exploded view of the cover of FIG. 22A.

FIG. 23A shows an exploded view of an incision closure applianceassembly comprising the incision closure appliance of FIG. 21 and thecover of FIG. 22A in accordance with the principles of the presentinvention.

FIG. 23B shows a perspective view of the incision closure applianceassembly of FIG. 23A adhered onto the skin of a patient.

FIG. 23C shows a top view of the elastomeric reinforcement layer of thecover of FIG. 22A.

FIG. 24A shows a perspective view of the incision closure applianceassembly of FIG. 23A adhered onto the skin of a patient in accordancewith the principles of the present invention.

FIG. 24B shows a sectional schematic diagram of the incision closureappliance of FIG. 23A adhered onto the skin of a patient in accordancewith the principles of the present invention.

FIGS. 25A-25C illustrate a method of applying the incision closureappliance assembly of FIG. 23A on the skin of a patient in accordancewith the principles of the present invention.

FIGS. 26A-26E illustrate embodiments of a cover for wound dressings andincision closure appliances in accordance with the principles of thepresent invention.

FIGS. 27A-27E illustrate embodiments of a wound closure appliance havinga medicinal agent incorporated thereon in accordance with the principlesof the present invention.

FIGS. 28A-28E illustrate embodiments of a wound closure appliance coverhaving a medicinal agent incorporated thereon in accordance with theprinciples of the present invention.

FIG. 29 illustrates another sacrificial cover positioned over anincision closure appliance in accordance with the principles of thepresent invention

DETAILED DESCRIPTION OF THE INVENTION

The apparatus and methods of the present invention will be used duringboth the formation and the closure of surgical incisions made to apatient's skin or other tissue during surgical procedures. As describedhereinafter, the direction of the incision will define both “axial” and“lateral” directions as those terms are used herein. Most incisions willbe made along a generally straight line which will define the axialdirection. The lateral direction will generally be across the axialdirection, typically but not necessarily being perpendicular or normalto the axial direction. Most incisions will be generally linear but insome cases the incisions could be curved or have other geometries. Theterm “axial” will then apply to the direction of the incision at anyparticular location, resulting in lateral directions which could alsovary.

Referring now to FIGS. 1-3, an incision closure appliance 10 comprises abase assembly 12 including a right panel 14 and a left panel 16. A rightforce distribution structure 18 is secured to the right panel 14,typically by laminating the force distribution structure to an uppersurface of the panel, and a left force distribution structure 20 issimilarly attached to an upper surface of the left panel 16. Theincision closure appliance further comprises a closure component 22which is removably attachable to the right and left forced distributionstructures 18 and 20 in order to close an incision, as described in moredetail below, and the appliance is completed with an optional securinglayer 24 which may be placed over the combined base assembly 12 andclosure component 22 after they have been secured to the patient and theincision has been closed by drawing the panels together using theclosure component.

The closure component 22 is intended and adapted to draw the innerportions of the force distribution structures 18 and 20 inwardly towardeach other to close a surgical incision which has been formedtherebetween. In the illustrated embodiment, a plurality of cleats 26are formed on lateral supports 36 which are held axially by spine 37 ofthe force distribution structures 18 and 20. The cleats 26 are receivedin slots 38 formed along inner edges of opposed engagement members 40 ofthe closure component 22. The opposed engagement members 40 are heldtogether by lateral struts 42 so that the engagement members are held ata fixed, laterally spaced-apart distance (in other embodiments thespaced-apart distance may be adjustable). The slots 38 are preferablyformed on flexible tab-like structures 44 which allow the slots to bepulled upwardly over the corresponding cleats in order to secure theclosure component 22 over the force distribution structures 18 and 20.

The lower surfaces 32 of each panel 18 and 20 will typically be coveredwith a pressure-responsive adhesive, where the adhesive is initiallycovered with a protective layer 48 which may be peeled away immediatelyprior to use. Additionally, pull-away tabs 50 or other similarstructures may be provided in order to hold the right and left panels 14and 16 together at a pre-determined spaced-apart distance after thelayer 48 has been removed but prior to adhering the panels to apatient's skin or other tissue surface. It is important that thedistance between the inner edges 28 of each panel 14 and 16 bemaintained as close as possible to the original target spacing so thatthe tissue edges, when closed by the closure component 22, will beprecisely brought together, typically with a slight eversion.

Referring now to FIGS. 4 through 7, a protocol for both forming anincision and subsequently closing the incision in accordance with theprinciples of the present invention will be described. Initially, theright and left panels 14 and 16 are placed on the patient's skinfollowed by reference letter S, as shown in FIG. 4. The panels 14 and 16are applied by first pulling away the protective layer 18 and placingthe panels onto the tissue, after which time the tabs 50 may be removed,leaving an incision path 52 defined between the inner edges 28. Thespacing of the inner edges 28 will be selected to provide a fixed,pre-determined distance d₁.

After the right and left panels 14 and 16 are in place, an incision Ican be formed in the space between the panels using a scalpel or othersurgical cutting device CD, as shown in FIG. 5.

After the incision I is made, a surgical procedure may be performed byopening the inner edges of the incision which in turn deforms the inneredges 28 of the right and left panels 14 and 16, as shown in FIG. 6. Asthe inner most ends of the supports 36 are not connected, they are freeto separate and allow the elastic matrix of the right and left panels 14and 16 to expand, as clearly in FIG. 6. The dimensional stability of theremainder of the panels, however, will be preserved by the lateralsupports 36 as well as the axial spines 37 which do not elongate underthe influence of the force applied by stretching opening the incision.

After the surgical procedure is complete, the closure component 22 willbe secured over the force distribution structures 18 and 20, asillustrated in FIG. 7. In particular, the slots 38 in the tab-likestructures 44 are engaged over opposed cleats 26 in order to drawopposed edges of the panels as well as of the tissue incision together.By properly spacing the depth of the slots 38, the closure component 22can be tailored so that the panels 14 and 16 are brought together by apre-selected distance d₂. Typically, the distance d₂ will be less thanthe initial separation d₁ so that the inner edges of the tissue arebrought together to cause the tissue edges along the incision toslightly evert (pucker upwardly) which can improve healing and reducescarring.

Optionally, as shown in FIG. 8, a closure component 22′ may includeengagement members 40′, where one end of each lateral strut 42′ isjoined by an adjustable clasp or other mechanism 54 so that the distancebetween the inner edges of the opposed engagement members 40′ can beadjusted in order to increase or lessen the distance d₂ therebetween.

An alternative embodiment 100 of the incision closure appliance of thepresent invention is illustrated in FIGS. 9 and 10. The appliance 100includes a base assembly 102 having a right panel 104 and a left panel106. A positioning or alignment strip 108 is provided to secure theinner edges of each panel together, as shown best in FIG. 10 andincludes an end tab 109 that allows the user to pull the strip from thepanels 104 and 106 after the panels have been put in place on a tissuesurface.

The incision closure appliance 100 further includes a backing 110 havingan end which may be partially folded back to expose an underlyingadhesive backing on the panels and allow that end of the base assembly102 to be adhered to the tissue while the remainder of the base assemblyis still covered by the backing. A securing layer 112 which includes areinforcement frame 113 is provided for placement over the right panel104 and left panel 106 after the base assembly 102 has been closed overan incision, generally is described in connection with the previousembodiment. Usually, a holding tray 114 will be provided for maintainthe components of the appliance together in a sterilized condition wherethe tray 114 will be covered with conventional medical packaging cover.

As illustrated in FIGS. 9 and 10, a right force distribution structure116 and a left force distribution structure 118 are provided on theupper surfaces of the right panel 104 and the left panel 106,respectively. The right force distribution structure 116 includes aright axial spine 120 and a plurality of lateral supports 122.Typically, the right axial spine 120 comprises a serpentine or zig-zagnumber which is embedded in or laminated to a base strip 121. Theserpentine axial spine 120 would typically be formed from a flexible,resilient plastic, typically a hard plastic, while the base strip 121will be comprised of a polyurethane or similar plastic layer. The lowersurface of the polyurethane layer will be covered with a hydrocolloidlayer for tissue adhesion. The structure of the left forced distributionstructure 118 will be the same including a left axial spine 124, leftlateral supports 126, and a left base strip 127.

The incision closure appliance 100 will include a closure mechanismcomprising a plurality of lateral tie assemblies 128 as shown on FIG. 9.As best seen in FIG. 10, each lateral tie assembly 128 will include arod which is secured at one end to the left lateral support 126 and aratchet mechanism 132 which is secured to the right lateral support 122.Each rod 130 will usually be aligned with the axis of the left panel 106parties so that a gap 129 between the right panel 104 and left panel 106will be left open so that an incision can be made there between. Afterthe incision is made, each rod 130 will be pulled over to the associatedratchet 132 on the right panel 104. A series of ratchet rings on eachrod will be pulled into the associated ratchet mechanism 132, and therod then pulled laterally until the desired closing tension is appliedat that point along the base assembly 102. It is a particular advantagethat each of the lateral tie assemblies 128 may be individually adjustedto supply the desired closing tension across the tissue along the lengthof the incision being closed. Once the desired closing tension has beenprovided along the entire incision, the securing layer 112 may be placedover base assembly 102 to hold the appliance and tissue in place.

Referring now to FIGS. 11A and 11B, an alternative design for thelateral tie assemblies 140 of the present invention is illustrated.These lateral tie assemblies 140 may be utilized with either of theincision closure appliances 10 or 100 described previously. Each lateraltie assembly 140 includes a right force distribution structure 142 and aleft force distribution structure 144. The right force distributionstructure includes a right spine 146 and a plurality of lateral supports148. Although three are shown, it will be appreciated that four, five,six or more lateral supports could be included. The left forcedistribution structure 144 similarly includes a left spine 150 and aplurality of left lateral supports 152. To provide closure, the rightforce distribution structure 142 includes a rod 154 which extends fromthe center lateral support 148. Typically, the rod 154 is joined to thesupport by a live or passive joint 158. A pull loop 156 is provided atthe free end of the rod 154, and a plurality of ratchet teeth 162 areprovided along the midsection of the rod 154.

The left force distribution structure 144 includes a ratchet mechanism160 adapted to receive the teeth 162 on the rod 154 of the right forcedistribution structure. In this way, the rod 154 can be lowered into theratchet 160 to engage teeth 162, allowing the rod to be pushed forwardin order to draw the right and left force distribution structures 142and 144 together in order to apply tension to the right and left panels.

As illustrated in FIG. 12, a further aspect of the present invention isillustrated. The incision closure appliance 100 is illustratedschematically with only the right and left panels 104 and 106 and theright and left force distribution structures 116 and 118 beingillustrated. The remaining system components are not shown for ease ofillustration.

The right panel 104 is covered by a right sacrificial cover 170 and theleft panel 106 is covered by a left sacrificial cover 172. The right andleft panels 104 and 106 may define a region 175 where the right and leftsacrificial covers 170 and 172 separates from the right and left panels104 and 106. Each cover 170 and 172 is detachably secured along eachedge of the associated base panel so that the covers remain in placeduring normal handling and placement of the incision closure appliance100 over the tissue surface to be incised. The use and purpose of thesesacrificial covers 170 and 172 is described with reference to FIGS. 13Aand 13E.

FIG. 13A illustrates the right and left panels 104 and 106 in place on atissue surface T prior to an incision being made. The right panel 104 iscovered by right sacrificial cover 170 and the left panel 106 is coveredby left sacrificial cover 172. As is common in many surgeries, anadherent surgical incision drape 180 is placed over the tissue surfaceT. Any conventional drape may be used such as the Ioban™ antimicrobialincise drape, available from 3M, St. Paul, Minn.

After the incision drape 180 is in place over the incision closureappliance, a surgical incision I may be made for performing a desiredsurgical intervention. As can be seen, the incision I will cut throughthe surgical drape 180 between the right and left panels 104 and 106,respectively. After the surgical procedure is completed, the surgicaldrape 180 will be removed from the tissue surface T. As the surgicaldrape has a lower adherent surface, prior to the present invention,removal of the drape might have displaced either or both of the rightpanel 104 and left panel 106. Presence of the sacrificial layers 170 and172, however, prevents such displacement. Removal of the surgical drape180 will remove the sacrificial layer 170 and 172, but as each of theselayers is configured to break off with a relatively low separationforce, removal of the sacrificial layers will not cause the underlyingpanels 104 or 106 to be displaced. Thus, the panels 104 and 106 will beleft in place, as shown in FIG. 13D, and the force distributionstructures 116 and 118 can be used as described previously for closingthe panels together to close the incision as shown in FIG. 13E.

Referring to FIG. 29, the right and left sacrificial cover layers 170and 172 may each be constructed from a thin sheet of urethane (e.g.,0.001″ thick). The middle of the urethane sheets may be adhered to thetop of the right and left panels 104 and 106, with the forcedistribution structures 116, 118 as well as any straps 130 and locks132, assembled on top of the urethane sheets. The urethane sheets maythen wrapped around the force distribution structures 116, 118 (and thestraps 130 may be bent inward as shown in FIG. 29 such that they arecontained over the panel 106) with the free ends of the urethanelaminated to one another along their length. Thus, the urethane sheetmay wrap over the force distribution structures 116, 118 and closureelements 130, 132 to protects them from the surgical drape 180. Theurethane sheet may preferably comprise a plurality of perforationsdisposed along its length and aligned adjacent with the inner and outeredges 104 e, 106 e of each panel 104, 106. The perforations may allowthe urethane sheet to tear away with the surgical drape 180 in acontrolled manner when a surgical drape, e.g., the surgical drape 180described herein, is removed. The perforations may preferably beconstructed of a 3 mm cut and 1 mm tie, though exact dimensions may bevaried to control the desired tear force. The perforations may be formedalong a single longitudinal line, or a plurality of lines. A pluralityof longitudinal perforation lines may allow for reliable separationdespite variations in which the surgical drape adheres to thesacrificial layers 170, 172. The perforations could be made to releasemore easily near the edge of the panels 104, 106 to help improve thelikelihood of separation near the edges 104 e, 106 e of the panels 104,106 and minimize excess urethane being left behind. To aid in the liftof the sacrificial layers 170, 172, tabs 170 t, 172 t may be adhered toeach end of the urethane wrap comprising the sacrificial layers 170,172. The tabs 170 t, 172 t may preferably be adhered to the inside ofthe upper surface of the urethane wrap. The tabs 170 t, 172 t may beshaped to prevent adhesion of the urethane to itself or to any exposedadhesive from the ends of each panel 104, 106. Pre-breaking of theperforations at the end of each panel 104, 106 may aid in the initiallift of the tab 170 t, 172 t and initiation of the tear by the user.

Referring now to FIGS. 14A1-14A3, further embodiments of incisionclosure appliances are illustrated. The base assemblies 1400 a (FIG.14A1), 1400 b (FIG. 14A2), and 1400 c (FIG. 14A3) may each comprise aright base panel 1402 and a left base panel 1404. The right base panel1402 may comprise an upper layer 1406 and a lower layer 1408. Similarly,the left base panel 1404 may comprise an upper layer 1410 and a lowerlayer 1412. The upper layers 1406, 1410 will typically be flexible butstiff enough securely close tissue and minimize disruption of theincision and surrounding tissue. The upper layers 1406, 1410 maycomprise a plastic layer made of rubber, latex, polyurethane, silicone,a thermoplastic elastomer, a woven fabric, a spun fabric, or similarmaterials. The adhesive bottom layers 1408, 1412 will typically beflexible and more elastic than the upper layers 1406, 1410 to follow anymovement of the underlying skin and tissue to maintain adhesion,minimize blistering, and otherwise reduce irritation. The adhesivebottom layers 1408, 1412 may comprise a hydrophilic adhesive materialsuch as a hydrocolloid, a hydrogel, an acrylic polymer, poly (ethyleneglycol), and the like.

The right and left base panels 1402, 1404 may comprise structures tofacilitate and limit axial and lateral stretching of the base assembly1400. These structures may also evenly distribute the closure forceexerted on an incision and may be disposed on the base assemblies 1400a, 1400 b, and 1400 c along their axial length. The right base panel1402 may comprise one or more right force distribution structures oraxial supports 1414. Each right axial support 1414 may comprise an axialsupport portion or spine 1414 a and two lateral support portions 1414 bcoupled to the axial ends of the spine 1414 a. Together, the spine 1414a and the two lateral support portions 1414 b form a C-shape which insome embodiments can open axially to a degree to facilitate axialstretching of the right base panel 1402 between two laterally adjacentlateral support portions 1414 b of adjacent supports 1414 while limitingthe axial stretching between the two lateral support portions 1414 b ofa single support 1414. In many embodiments, the C-shaped axial support1414 is only flexible enough to allow flexing vertically but is stiff tominimize axial and lateral stretching. As shown in FIG. 14A1, the rightaxial supports 1414 may be inward facing. As shown in FIGS. 14A2 and14A3, the right axial supports 1414 may be outward facing which may helpto distribute any mechanical load against the tissue closure to theincision I between the right and left base panels 1402, 1404. Similarly,the left base panel 1404 may comprise one or more left forcedistribution structures or axial supports 1416. Each left axial support1416 may comprise an axial support portion or spine 1416 a and twolateral support portions 1416 b coupled to the axial ends of the spine1416 a. Together, the spine 1416 a and the two lateral support portions1416 b form a C-shape which in some embodiments can open axially to adegree to facilitate axial stretching of the left base panel 1402between two laterally adjacent lateral support portions 1416 b ofadjacent supports 1416 while limiting the axial stretching between thetwo lateral support portions 1416 b of a single support 1416. In manyembodiments, the C-shaped axial support 1416 is only flexible enough toallow flexing vertically but is stiff to minimize axial and lateralstretching. As shown in FIG. 14A1, the left axial supports 1416 may beinward facing. As shown in FIGS. 14A2 and 14A3, the left axial supports1416 may be outward facing which may help to distribute any mechanicalload against the tissue closure to the incision I between the right andleft base panels 1402, 1404.

As shown in FIG. 14A3, the base panel assembly 1400 c may furthercomprise skirts 1424 and 1426. The skirts 1424, 1426 may be similar tothe thin base assembly covers described below. For example, each skirt1424, 1426 may comprise a 0.001 inch thick urethane film coupled to a0.002 inch thick acrylic adhesive. The adhesive may be applied to thewhole under-surface of the skirts 1424, 1426 or may just to the regionof the skirts 1424, 1426 beyond the base panels 1402 or 1404. Duringconstruction of the base panel assembly 1400 c, the skirts 1424, 1426may be applied directly over all or a portion of the adhesive layers1408, 1412, respectively. The skirts 1424, 1426 may be applied in placeof, or in addition to, the thin film upper layers 1406, 1410,respectively. Release liners as described herein may further be providedto line the adhesive under-surface of the skirts 1424, 1426. The skirts1424, 1426 may extend beyond the outer border of the base panels 1402,1404, respectively, by 8 mm or in a range of 1 to 20 mm, for example,but does not span across the lateral area between the base panels 1402,1404 to improve the ability to visualize and/or clean the incision site.Thus, the skirts 1424, 1426 may help provide additional adhesive supportand/or creep reduction to the adhesive layers 1408, 1412 of the basepanels 1402, 1404 without having to align and place a separate cover orcover sheet over the base panel assembly 1400. After manufacturing, theskirts 1424, 1426 are typically already precisely aligned relative tothe base panels 1402, 1404. A separate cover or cover sheet as describedherein may still be used to prevent tampering of the incision site andcomponents of the base panel assembly 1400 c. As the skirts 1424, 1426already laterally extend over the base panels 1402, 1404, respectively,such a separate cover or cover sheet may not require precise placementrelative to the base panel assembly 1400 c and could be more narrowcompared with other covers or cover sheets described herein.

One or more perforations 1418 may be provided in-between axiallyadjacent right axial supports 1414 on right panel 1402 to facilitate theaxial and/or lateral stretching of the right base panel 1402. Theperforations 1418 may be all the way through the upper and lower layers1406, 1408 to provide aeration to the underlying tissue or may only bepresent on the upper layer 1406. Similarly, one or more perforations1420 may be provided in-between axially adjacent left axial supports1416 on left panel 1404 to facilitate the axial and/or lateralstretching of the base panel 1402. The perforations 1420 may be all theway through the upper and lower layers 1410, 1412 to provide aeration tothe underlying tissue or may only be present on the upper layer 1410. Asshown in FIG. 14A1, there may only be a single perforation 1418 or 1420between the axial supports 1414 or 1418. As shown in FIGS. 14A2 and14A3, there may be a plurality of perforations 1418 or 1420 in a lateralline between the axial supports 1414 or 1418. The perforations 1418,1420 may also reduce the stress incurred as the skin stretches radiallyoutward from the incision I such as during joint articulation andswelling.

A plurality of perforations 1418, 1420 may, for example, be providedin-between the axial ends of the right and/or left axial supports 1414,1416 along the right and left lines 1424, 1426 shown in FIG. 14B. Aplurality of axially-aligned perforations may be provided on each linesegment 1424 or 1426 such that at least the upper and lower layers 1410,1412 of the base panels 1402, 1404, respectively, may break intoseparate segments when axially stretched as further described below. Insome instances, during the wear duration of the device 1400, theperforations 1418, 1420 may allow the layers 1406 and 1408 of rightpanel 1402 and the layers 1410 and 1412 of left panel 1404 to completelydivide and separate at the perforation line, which is shown in FIGS.14A2 and 14A3. The ability to completely divide and separate furtherallows the skin to stretch axially as needed, with the elongationallowed (and limited) by the linkages of axial supports 1414 and 1416and closure components 1422 discussed below. As discussed herein, aflexible, compliant cover may be applied over the base panels 1402, 1404after the incision I is closed. The cover may further serve to provide(and limit) axial and lateral movement of the base structure 1400 b.Alternatively or in combination, one or more of the right or left basepanels 1402, 1404 may be laterally cut and separated in-between theforce distribution structures or axial supports 1414, 1416 to facilitatethe axial and/or lateral stretching of the right and/or left base panels1402, 1404.

To couple the right and left base panels 1402, 1404 laterally togetherand optionally to tighten the right and left base panels 1402, 1404against one another, the base assembly 1400 may further comprise aplurality lateral closure components or tie assemblies 1422. The lateralclosure components or tie assemblies 1422 may comprise a ratchetmechanism similar to that of lateral tie assemblies 128 and 140described above. The lateral tie assemblies 1422 may couple laterallyadjacent right and left axial supports 1414, 1416 together, typically attheir axial ends. As shown in FIGS. 14A1-14A3, the placement of theright and left axial supports 1414, 1416 on the right and left panels1402, 1404, respectively, may be staggered or axially offset, and theright and left axial supports 1414, 1416 may be C-shaped structures withlateral end portions 1414 b, 1416 b that laterally face and align withone another (and are connected to one another by a lateral tie assembly1422). For example, the far end lateral portion 1414 b of a first rightaxial support 1414 may be laterally aligned with the near end lateralportion 1416 b of a first left axial support 1416, the far end lateralportion 1416 b of the first left axial support 1416 may be laterallyaligned with the near end lateral portion 1414 b of a second right axialsupport 1414, and so forth. Thus, the lateral tie assemblies 1422 andright and left axial supports 1414, 1416 may be connected to one anotherto form a line of consecutive lateral tie assemblies 1422 and right andleft axial supports 1414, 1416, and this line may have a serpentinearrangement that laterally spans the right and left base panels 1402,1404 (i.e., goes across the distance between the right and left basepanels 1402, 1404) as shown in FIGS. 14A1-14A3. The serpentinearrangement of lateral tie assemblies 1422 and right and left axialsupports 1414, 1416 may one or more of evenly distribute the closureforces provided by the base assembly 1400 on an incision, provide (andlimit) axial flexibility of the base assembly 1400, and provide rigidityor stiffness to the base assemblies 1400 a, 1400 b, and 1400 c tosufficiently close an incision and allow it to heal with minimizeddisruption and distension (i.e., provide lateral and axial stability).In many embodiments, the lateral supports 1414, 1416 are stiff so thatthe areas of the base panels 1402, 1404 that are not covered with thelateral supports 1414, 1416 stretch. Because these uncovered areas areoffset from one another from the right base panel 1402 to the left basepanel 1404, the tie assemblies 1422 may pivot axially from their anchorpoints as the incision I is axially stretched. Such axial pivoting ofthe tie assemblies 1422 may bring the left and right panels 1402, 1404closer together to maintain the closure of the incision I.

The material of the lateral tie assemblies 1422 and the right and leftaxial supports 1414, 1416 may include, for example, a flexible,resilient plastic, typically a hard plastic, such as Nylon,Polypropylene, Polyethylene, Poly carbonate, and other thermoplasticpolymers. Often, the lateral tie assemblies 1422 and the right and leftaxial supports 1414, 1416 may comprise a material less elastic than thatof the right and left base panels 1402, 1404. Thus, as with many otherbase assemblies of incision closure appliance disclosed herein, greaterstiffness (and less elasticity) may be provided toward the top of baseassemblies 1400 a, 1400 b, and 1400 c. In other words, there may be anelasticity gradient between the top and bottom of the base assemblies1400 a, 1400 b, and 1400 c. The tops of the base assemblies 1400 a, 1400b, and 1400 c may be sufficiently rigid or stiff so that the incisionclosure appliance, when applied to an incision and surrounding tissue,prevents movement of tissue laterally adjacent the appliance to notsubstantially distend the covered incision and surrounding tissue. Thatis, movement of at least a portion of the applied incision closureappliance (e.g., a portion below the more stiff layers) is collectiveand does not disrupt the underlying incision. And, the bottoms of thebase assemblies 1400 a, 1400 b, and 1400 c may be sufficiently elasticsuch that blistering and adhesion loss due to movement of tissueadjacent the applied incision closure appliance are minimized. While aprimary function of lateral tie assemblies 1422 may be to apply tensionto each base panel 1402, 1404 to hold the incision I closed, in manyembodiments, the lateral tie assemblies 1422 may also serve to providecolumnar strength so as to isolate the incision I by minimizing effectsof compression on (or bending/creasing along) the incision I fromdistraction forces that could disrupt the incision edge alignment andapposition. The axial spacing, material property, and dimension of thelateral ties 1422 may be optimized for sufficient axial bendingflexibility and lateral compression and bending support. In preferredembodiments, the spacing between ties 1422 is 10 mm, the material of theties 1422 is nylon, and the dimension is a round cross-section of 0.030inch.

Referring now to FIG. 14B, the base assembly 1400 b may be placed overan incision in the skin of a patient or subject's joint, such as theknee. In incisions placed in proximity to articulating joints, the kneein particular, closure device or closure appliance integrity is oftenchallenged by a number of factors. These factors include longitudinalelongation, circumferential swelling, opening of the wound asarticulation occurs, skin damage such as blistering, adhesion loss, andpassage of wound exudates. Joints such as knee, elbow, ankle, andshoulder may undergo a movement which can sometimes result inarticulation covering more than 135° movements, leading to thechallenges noted above.

In a bent position, the skin around the knee can stretch up to 50%axially (i.e., parallel to the incision) and laterally (i.e., transverseor perpendicular to the incision). An incision closure appliance adheredto the skin in this area may preferably be able to provide enoughtension to close the incision yet accommodate the stretch with minimallocal stress. Minimizing the local stress may prevent local skinadhesion loss or damage to the skin if the adhesive loss does not occur.An important property for many incision closure appliances disclosedherein is the ability of the tension load of the appliance's closureelements to be distributed across an area larger than that of thetension element attachment point itself. Furthermore, the structurecomprising the adhesive to which the tensioning elements are attachedmay in many cases have the ability to distribute the compliance of thestructure across the region of skin stretch such that the applianceholds the incision in place while the skin moves around it. Embodimentsdescribed herein may include a composite design of non-stretchingtension elements (commonly referred to as “straps”) that are linked to“locks” that hold the straps in place. For example, such elements mayinclude the lateral tie assemblies 128, 140, and 1422 described above.These elements may be mounted over skin adhesives with elastic polymericmaterials that help distribute the tension load. Such elastic polymersmay in many cases have high elongation before yielding or permanentlydeforming and may include thermoplastic elastomers such as polyurethaneas well as various grades of silicone. Such materials may also be easilyformed into thin films necessary for maintaining a low profile andsufficient compliance.

The skin adhesive used in the appliance may also need to withstand theelongation of the skin and be able to retract/recoil when the skin isreturned to an un-stretched condition (e.g., in the fully extended kneeposition). Hydrocolloid adhesives may provide such properties and may bepreferably suited for this application. Other adhesives such as acrylicmay also be used to provide this property. In general, such adhesivesmay need to be attached to an elastic thin film such as that describedabove in order to hold their structure during expansion and recoil.Without such support, the adhesive may tear and separate with repeatedelongation.

Incision closure appliances constructed as a sequence of short segmentsmay accommodate higher overall elongation without loss of adhesion orskin damage. Each individual segment may be subjected to the localstretching of the skin under it. The space between two adjacent segmentsmay act as stress relieving space allowing the skin to stretch in thatspace. The segmentation may be achieved in number of ways: (1) by layingdown individual segments along the incision line, or (2) allowing thedevice to divide into short segments as it is applied to the skin orafter applying to the skin.

A preferred means of achieving segmentation after application to theskin comprises creating perforations (e.g., a lateral line ofperforations to facilitate tearing) in the polyurethane layer (i.e., theupper layer 1406, 1410 of a base panel 1402, 1404) as described aboveand leaving the underlying adhesive intact, as shown in FIG. 14B. Theperforations may result in tearing of at least the upper layers (e.g.,upper layers 1406, 1410) of the base panels along the perforated lines(e.g., lines 1424, 1426) when it undergoes stretching as the knee flexes(i.e., is articulated). In preferred embodiments, the adhesive panel oneach side of the incision may be 12 mm wide, and the perforations withina given panel are spaced about 12-20 mm apart. Experimentation wasperformed and showed that a perforation of 3 mm cut and 1 mm tiedistances are effective in achieving segmentation in 0.001 inch thickurethane base panels when the knee flexes. As the knee flexes, the skinmay elongate in axial (along the incision) and lateral directions up to50% in some locations. Separation of the polyurethane can thus relievestress in the device as it undergoes stretch.

As an example, a surgically repaired knee may be inflamed for a numberof days, which may result in approximately 30% radial swelling of thejoint after closure. Elastic materials like polyurethane may allow theincision closure appliance (for example, including the base assembly1400 b adhered to the resulting incision I in FIG. 14B) to expand withthis circumferential swelling. Minimizing the width of the appliance(e.g., 12 mm or less for each base panel segment 1402, 1404) mayminimize the amount of the appliance subject to expansion in a directionperpendicular to the incision I, and may thus preserve adhesion whileminimizing potential for skin damage. FIG. 14B shows perforations inadhesive segments running in the lateral direction to the incision alonglines 1424, 1426 to allow easier stretch axially. Perforations or otherfenestrations could also be made near the outer edges of the adhesivesegments parallel to the incision in order to reduce the stress incurredas the skin stretches radially outward from the incision such as duringarticulation and swelling.

Referring now to FIGS. 15A-15D, an incision may often experience forcesthat tend to open the incision due to the flexion of the knee or otherjoint. In many embodiments, an incision closure appliance is providedwith a locking mechanism that counters the opening forces by closingtightly during flexion to assist in keeping the incision closed. FIGS.15A and 15B shows a base assembly 1500 of an incision closure appliancethat comprises a mechanism that leverages the pulley effect, i.e., whenthe skin stretches along the incision, the distance between the lockingpoints on either side of the incision shortens. In preferredembodiments, the adhesive panels 1510 a, 1510 b on each side of theincision between the base panel 1510 a, 1510 b pairs is 12 mm wide, andthe lined perforations 1530 within a given panel 1510 are spaced about18 mm apart. Typically, all the members of the locking mechanism arenon-stretching. The triangle formed by the anchor 1540, pulley 1520,lock 1550, and flexible locking element 1580 (e.g., a tether or a strap)has its base B axially along the incision and its height H laterallyacross the incision, as shown in FIG. 15C. As the knee flexes thetriangle base length increases. Typically, all the members of thetriangle are non-stretching, which requires that the height mustdecrease in order to preserve the length of individual elementsconnecting between any two points, resulting in additional closureforces across the incision. FIGS. 15A and 15B further show that thelower surfaces of the base panels 1510 a, 1510 b may comprise ahydrocolloid adhesive 1560 and one of the panels 1510 a or 1510 b maycomprise a locking arm 1570 for locking the strap 1580 in place. Whilethe base of the triangle is shown in FIG. 15A on the left base panel1510 b, it is contemplated that the base of the triangle may instead beon the right base panel 1510 a.

While a triangle is formed by the anchor 1540, pulley 1520, lock 1550,and flexible locking element 1580 other shapes are also contemplated.For example, the pulley 1520 may be wrapped around two anchors 1540 toform a square or rectangular shape, or the pulley 1520 may be wrappedaround three or more anchors 1540 to form a trapezoid shape. Referringto FIG. 15D, a base assembly 1500 a of an incision closure appliancewhich is similar to the base assembly 1500 is shown. In the base panel1500 a, the anchor 1540, the two pulleys 1520, the lock 1550, and theflexible locking element 1580 form a rectangle to provide additionalclosure at the incision I when the underlying skin stretches. In therectangular configuration shown in FIG. 15D, the spacing between the twofixed points on either side of the incision I will typically be thesame. Whereas in the triangular configuration shown in FIGS. 15A and15C, the fixed points on the pulley 1520 side may be spaced furtherapart than the other side of the incision I. While the rectangle isshown as “open” on the left base panel 1510 b, it is contemplated thatthe rectangle may be “open” on the right base panel 1510 a instead.

In the incision closure appliance base assemblies 1400 a, 1400 b, and1400 c shown in FIGS. 14A1-14A3 and other described herein, individualstraps 1422 may be used to engage individual locks on the opposite sideof the incision I. In FIGS. 15A-15D, each flexible locking element orstrap 1580 is typically anchored on one side of the incision I, wrapsaround the other side, and then engages a lock 1550 on the same side ofthe incision I as the location of anchor 1540. In the embodiment shownby FIG. 15D, the flexible locking element or strap 1580 wraps around twofixed spools (bobbin/pulley 1520) on the other side of the incision Ibefore engaging the lock 1550 on the same side. The spools 1520 aroundwhich the flexible strap 1580 are wrapped may preferably be linked witha rigid member so that the distance between them does not increase whenthe closure device base panel assembly 1500 is elongated in the axialdirection. In alternative embodiments, allowing expansion between thepulleys or spools 1520 may be desirable. It should be noted that theflexible locking element 1580 may be anchored in one base panel segmentwhile locked in the adjacent segment separated by perforations 1530 inthe base panel 1510 a or 1510 b. Such anchoring and locking may create aconnection among three segments of the base strips—two on the same sideand one on the other. When taken together across the length of theincision closure device or base assembly 1500 or 1500 a, the attachmentmechanism forms a continuous ‘S’ shaped (i.e., serpentine) connectionsacross the incision I.

The tensioned flexible connectors 1580 which wrap around the spindles,spools, or pulley 1520 may be configured to provide extra compression ofthe incision I when the distraction forces attempt to open the incisionand the underlying skin experiences stretching. The flexible strap 1580may in some cases potentially slip from the spindle 1520 and becomeloose if the two base panels 1510 a are further compressed by externalforces brought together without any stretching of the underlying skin.To prevent such slippage from occurring, the flexible wrapping member1580 can be slideably contained or anchored within an element 1590anchored on the base strip 1510 a. FIGS. 15E and 15F show the flexibleelement 1580 threaded through a tube 1590 which in turn is attached oranchored to the base panel 1510 a. When the base panels 1510 a, 1510 bare brought closer together, the flexible strap element 1580 will stillbe captured and will continue to provide the necessary closure function.In other embodiments, the spool features 1590 shown in FIGS. 15E and 15Fmay have holes through the center which the strap 1590 slides through.The flexible strap 1580 and element 1590 it slides through maypreferably be designed to minimize friction between the elements 1580and 1590.

Experimentation was performed and showed that where the base B is 12 mmand the height H is determined by the distance between the strapconnecting points on the two base panels 1510 a, 1510 b after theincision is closed (typically about 16 mm), flexing of the appliance1500 on a human knee resulted in the height H decreasing by 5% in theareas where the elongation of the skin S was maximum. It should be notedthat the decrease in height may be dependent on a number of factors suchas base of the triangle, level of elongation of the underlying skin anddistance between the two bases on either side of the incision. Theconnecting “straps” between the anchors 1540 and the locks 1550 may needto be at least partially flexible to allow looping around the pulley. Inpreferred embodiments, a monofilament plastic thread is integrated withfeatures that engage into a locking mechanism. Such features could berounded “teeth” that engage in a ratchet-like mechanism within the lock.Such a plastic can be used to achieve the desired flexibility,longitudinal rigidity, low propensity to harbor bacteria, and allow forextrusion and/or injection molding processes. A braided suture(preferably coated to limit harboring of bacteria) can also be used tocreate flexible yet un-stretchable connectors. A round wire or tubingmade out of flexible material like silicone can also be used to achievethe flexibility. The strap of the pulley could be a composite ofmaterials such as molded plastic and braided suture. In otherembodiments, the strap of the pulley can be formed by necking a moldedstrap. Pulling a molded strap beyond its yield point can reduce thecross-section of the strap permanently and make it more flexible when itelongates. Heat can be used in the necking process to facilitateelongation and reduction in the cross-sectional area. Alternativemechanisms shown in FIGS. 16A-16B can be used for locking strapmaterials such as suture and softer plastic once desired closure isachieved. FIG. 16A shows a locking mechanism comprising a slot forsliding 1610 and an anchoring frame 1620. FIG. 16B shows a lockingmechanism comprising a locking tooth 1630. FIG. 16C shows a lockingmechanism comprising a slot for sliding 1640 and an anchoring frame1650. FIG. 16D shows a locking mechanism comprising a cylindrical tube1660 and locking teeth 1670.

The additional closure force across the incision when the knee flexesmay be achieved by using a hinging mechanism 1700 as shown in FIG. 17.As shown in FIG. 17, the four points on either side of the incision (twoanchor points 1720 on each side or base panel 1710 of the incisionclosure appliance) may be connected with non-stretching arms 1730 in theshape of an X, with hinging provided at the intersection 1740. As theknee flexes and the distance between two points on the same side of theincision increases, the distance between the segments on either side ofthe incision may decrease, resulting in additional closure force. Asshown in FIG. 17, the base panels 1710 may also be provided with aplurality of perforations 1750 to facilitate axial stretching to thebase panel 1710 or its separation into discrete segments upon axialstretching.

As shown in FIG. 18, the straps and locks of an incision closureappliance 1800 according to many embodiments can be configured to forman S-shaped or serpentine connection or arrangement across the entirelength of the incision I on the skin S of a knee. The incision closureappliance 1800 may be similar in many respects to the incision closureappliance 1400 described above. The segments 1810 a, 1810 b of thedevice 1800 are connected to each other by connecting each segment 1810a on one side of the incision I with two adjacent segments 1810 b on theopposite side of the incision. This may be achieved by mounting a pairof straps 1820 in each segment 1810 a and a pair of locks 1830 on thecorresponding segments 1810 b on the other side. Each pair of locks 1830and straps 1820 may be connected with each other. During closure of thewound or incision I, one of the straps 1820 (e.g., strap 1820 a) of abase panel segment 1810 a (e.g., 1810 a 1) may be connected with a lock1830 (e.g., 1830 a) on a segment 1810 b (e.g., segment 1810 b 1) on theother side of the incision I and the second strap 1820 (e.g., strap 1820b) may connected with a lock 1830 (e.g., 1830 b) in the segment 1810(e.g., segment 1810 b 2) on the opposite side of the incision I adjacentto segment 1810 b (e.g., 1810 b 1) in which the previous paired strap1820 (e.g., strap 1820 a) was connected. The aforementioned connectionsform a single loop of the S-shaped or serpentine arrangement of basepanel segments 1810, straps 1820, and locks 1830. Perforation lines 1850may separate axially adjacent base panel segments 1810 a and 1810 b. Theperforation lines 1850 on one side (e.g., with base panel segments 1810a) may be staggered with the perforation lines 1850 on the other side(e.g., with base panel segments 1810 b). Similar to FIG. 15A, inpreferred embodiments, the adhesive panel on each side of the incisionmay be 12 mm wide, and the perforations within a given panel may bespaced about 18 mm apart.

Incision closure appliances or devices as described herein may beapplied in many ways. FIG. 19 shows an example incision closureappliance 190 according to some embodiments. Here, individual base pairsegments 1910 arranged in pairs may be provided on individualcarrier/release liners. Each base panel segment 1910 pair comprises astrap 1920 and lock 1930 that may be independently aligned with theincision and adhered to skin adjacent to each other. Individual segments1910 may be held together in relation to one another with a releaseliner and outer carrier tape 1950. The release liner 1950 may be removedto expose the adhesive, but the entire device 1900 or grouped portionsof the device 1900 may be linked with the outer carrier tape. Uponapplication to the skin, the carrier tape 1950 may be removed, leavingadhesive segments 1910 which are aligned with one another but can moveindependently.

Perforated segments of base panel upper layers, typically comprisingpolyurethane, may be held together with a continuous layer of theadhesive bottom layer, typically comprising a hydrocolloid adhesive, toallow laying down on the skin in one continuous motion. The incisionclosure appliances 1400, 1500, and 1800 of FIGS. 14A-14B, 15A-15C, and18, respectively, may be provided with such a continuous adhesive bottomlayer.

The base assembly or base panels of the incision closure appliancesdescribed herein preferably may be covered with a flexible adhesive filmmaterial at the end of a wound or incision closure. This film areapreferably may be larger than the base incision closure panel elementssuch that it overlaps the elements onto the skin. The film may helpprevent migration of the base and may prevent any accidental movementsof the anchors and locking mechanisms. The cover film may be made fromstretchable materials like rubber, latex, polyurethane, silicone orthermoplastic elastomer, etc. In preferred embodiments, a thin cover(e.g., laminate of 0.001″ urethane and 0.002″ thick acrylic adhesive),will have a greater compliance than the composite structure of the basepanel elements. As a result, the cover may offer some strain reliefbetween the exposed skin and the base segments. The cover may also betransparent to allow visual inspection of the incision. The cover maycompletely seal across the incision (e.g., as a barrier to infection) orthere may be openings in the cover that are aligned with the incisionline to allow passage of any exudates from the wound. The cover may alsoserve to improve the apposition of the incision edges by bridging thebase panels and adhering to the skin edges between the base strips. Thecover may also be constructed with additional reinforcing elements thatimprove the tensile strength between the base panel elements but allowfor compliance along the incision length. A preferred embodiment maycomprise a series of polyethylene adhesive tape strips applied to thecover.

While the user may apply the cover after the base assembly and panelsare placed on the skin, it is also conceived that the cover material maybe supplied as a “skirt” extending around the outer perimeter of thebase segments. Thus, alignment of the cover materials relative to thebase may not be dependent on the user placement. These same covermaterials may provide the effects of preventing exposure of thehydrocolloid adhesive to patient clothing, limitation of migration ofthe hydrocolloid or other adhesive lower layer, providing strain relieffor the tension on the base segments, etc.

In many embodiments, a hydrocolloid adhesive is used for tensioning skinfor incision closure. The hydrocolloid may be prevented from creep byone or more of (1) using a laminate on the surface to limit creep or (2)applying an adhesive cover across the skin and the hydrocolloid adhesiveto prevent creep and to provide strain relief to the skin to preventskin damage.

In many embodiments, a cover as used with the base assembly may includeone or more of perforations or openings to allow removal of woundexudate (as well as any applied bandages/absorbant material) withoutremoval of the adhered base assembly.

In many embodiments, the cover comprises a composite of flexibleurethane and reinforced strips. The composite construction may providestrength across the incision as well as provide for compliance along theincision length.

In many embodiments, the cover in combination with the base assemblyaligns the skin incision edges or significantly prevents subsequentmisalignment of the skin edges, in both the axial and lateraldirections.

In many embodiments, cover liner configurations are provided such thatpart of the cover can be applied to the skin first, which then aids inthe removal of other liners and thus may help control the thin materialsso they lay out evenly with minimal wrinkling.

In many embodiments, the removal of a first liner may allowvisualization during placement and may prevent the remainder of thedevice from sticking to the user.

Referring back to FIGS. 9 and 10, two adhesive panels 104, 106 are inmany preferred embodiments applied to either side of a surgical incision(either before or after the incision is made). A closure mechanism maybe mounted on top of the adhesive panels 104, 106 and may be preferablyattached to a component 120 which helps to distribute the closure forcesbetween attachment points of the closure mechanism. As shown in FIGS. 9and 10 as well as FIGS. 20A and 20B, this closure mechanism may comprisea strap 130 and a lock 132. The strap 130 may comprise an elongatedcomponent with engagement teeth. The lock 132 may comprise a feature forcapturing the engagement teeth of the strap 130. The strap 130 may betightened in the lock 132 to pull the adhesive panels 104, 106 (and thusthe incision edges) together. The user may disengage and re-engage thestrap 130 in the lock 132 as necessary to properly adjust the amount ofskin closure. Together, the incision closure appliance illustrated inFIG. 20A may be described as the base or base assembly 102.

The skin adhesive used for each panel 104, 106 may preferably comprise ahydrocolloid adhesive. Alternatively or in combination, the skinadhesive may comprise one of many acrylic formulations known in the art.Hydrocolloid adhesives may have the benefit of being very tacky and ableto absorb moisture and shedding skin cells. Thus, hydrocolloid adhesivesmay be particularly suited for long-term wear applications (e.g., up to14 days). In at least some instances, the hydrocolloid structure may besoft, however, and may be prone to creep under tension unless reinforcedin some manner such as by covering the hydrocolloid adhesive layer withstiffer base panels 102, 104 or other covering structures disclosedherein.

Accordingly, a further aspect of the present invention also providesvarious means of reinforcing and protecting the adhesive layer in thebase assemblies of the incision closure appliances described herein aswell as additional means of holding the skin edges together,particularly in the axial direction. In at least some cases, thehydrocolloid adhesive alone has very low tensile strength and mayrequire a means of reinforcement to prevent it from tearing or creepingduring use. As illustrated in FIG. 21, the adhesive layer 211 used inthe base panels 104, 106 may be laminated with a thin layer of acompliant plastic or polymer 212, such as urethane, preferably 0.001inch thick, with a potential range up to 0.010″ thick, that may helps tomaintain its structure during clinical use. The adhesive layer itselfmay nominally be 0.010 inch thick, but may range between 0.005 inch and0.020 inch thick. Because tensioning elements comprising straps 130 orlocks 132 attached to a load distribution component 118 may be mountedto the top of the adhesive structure 211, the possibility exists thatthe material could creep over time. The laminate 212 as well as anyother adhesive laminates 215 a, 215 b between the adhesive layer 211 andthe load distribution component 118 may help provide the structure toprevent creep of the adhesive layer.

To further prevent migration of the adhesive panel 211, a cover 220 mayalso be applied over the panels 104, 106 as shown in FIG. 22A. As shownin FIG. 22B, the cover 220 may comprise a thin, adhesive coatedcompliant elastomer 221. In many embodiments, the cover 220 furthercomprises a thin urethane layer (preferably 0.001 inch thick) coatedwith a skin adhesive, such as an acrylic adhesive (preferably 0.002 inchthick), which may be provided on one or more release liners 223 a, 223b. The cover may further comprise reinforcing features 225.

As shown in FIGS. 23A and 23B, the cover 220 may be constructed suchthat it may extend beyond the base panels 104, 106, thereby bridging adistance, d3, between the skin S and the panels 104, 106. A typicalminimum necessary distance, d3, may be 8 mm but could range 2-15 mm.Besides helping prevent creep of the adhesive layer of the base panels104, 106, the urethane skin adhesive of the cover 220 may also help tostrain relieve the tension applied to the base panels 104, 106 frommovement of the surrounding skin S. This may serve to prevent skindamage (e.g., from erosion or blistering) at the base panel 104, 106edges. It should be noted, however, that the compliant nature of thehydrocolloid offers local protection from blistering by itself beingable to move with the skin S and thus resist damage to the skin S. Inmany embodiments, even with stiffer structures mounted to the outersurface of the adhesive layers, the compliance within the nominal 0.010″thickness of the adhesive layers down to the skin surface may provideresistance to skin damage.

Besides stabilizing and strain relieving the base panel structures, thecover 220 may serve other purposes. By covering the location where astrap 130 would engages a lock 132, the cover 220 may prevent thepatient from tampering with the locks 132 to the point where the straps130 could be disengaged. As shown in FIGS. 23A-23C, the cover 220 may befitted with openings 224, 224′ along the length of the regionoverlapping an incision, such that externally applied gauze may absorbwound exudate. In other embodiments, the cover 220 may not have openingsin order to protect the wound from sources of infection. The cover 220itself may have reinforcing features 225, 225′ to provide the base 102with additional resistance to the incision opening, particularly inregions between the straps 130. FIG. 23C shows a particular embodimentwhere the reinforcing features 225′ could be rectangular strips ofadhesive tape. The tape 225′ may preferably be stiffer perpendicular tothe skin incision than the surrounding compliant urethane layer 221. Thetape 225′ may be constructed from any combination of adhesive coatedwoven fabric, polymer fibers, polyethylene, polypropylene, nylon, PET,hydrocolloid, or other materials known in the art. The reinforcingfeatures 225′ may also add “body” or stiffness to the cover 220 to aidin its placement. The urethane layer 210 may be constructed of suchmaterials to give it a bi-directional stretch.

The spacing of the reinforcing features 225, 225′ may be important toensure the longitudinal (parallel to the incision line) compliance ofthe cover 220 (e.g., due to the compliant thin urethane). This may serveto improve patient comfort and the resistance to skin damage by allowingthe cover 220 and the underlying base assembly 102 to move with motionsof the body. This effect may be from the cover 220 alone or as acomposite effect with features on the base assembly 102 which may allowlongitudinal compliance. The reinforcements 225, 225′ may also be of auniform construct, but perforated, slit, or otherwise mechanicallyinterrupted to allow stretch and/or controlled tearing with body motion.The thin urethane layer(s) of the cover 220 may also be mechanicallyinterrupted to the same effect. In at least some cases, the reinforcingfeatures 225, 225′ of the cover 220 may not extend the entire width(perpendicular to incision) of the cover 220. This limited coveringwidth may help ensure strain relief to the body motion away from thebase assembly 102 perpendicular to the incision I. In preferredembodiments, the region of the cover 220 reinforced by the reinforcementmembers 225, 225′ extends 10 mm in each direction away from the incisionedge, but this may range from 2-50 mm.

Another feature of the cover 220 may be to be able to add control to theincision edge, particularly between the tensioning elements 130, 132 ofthe base assembly. As illustrated in FIG. 24A, the tensioning elements130, 132 combined with the base panels 104, 106 may serve to approximatethe incision edges 205 together. Once the skin S is approximated, it maybe important that the skin edges be aligned vertically (perpendicular tothe skin surface). Vertical misalignment may lead to slower healing andvisible “step-off”, or ledge, in the incision that may result in poorscar cosmesis. By having portions of the cover 220 adhere to each edgeof the base panels 104, 106 along the incision, each edge may held undertension in vertical alignment as shown by arrows 201 a, 201 b. Adhesiveon portions of the cover 220 crossing the incision I may also adheredirectly to the skin S at the incision edge, further shortening thedistance between the adhered incision edges and further enhancingvertical skin alignment. In preferred embodiments, the portions of thecover 220 crossing the incision I are rectangular strips 225′ ofadhesive tape as shown in FIG. 23C. The width of each strip 225′ and theaxial gap between the strips 225′ may be optimized for incision edgecontrol, incision visibility, and the escape of wound exudate. Apreferred embodiment may comprise a strip 12 mm wide and spaced 6 mmapart, with the straps located between each strip. Other widths andspacing are also contemplated. By not bridging/tenting over each strap130, the strip 225 may lay flatter against the skin S for betteradhesion and edge control.

In some embodiments, the reinforcing features 225, 225′ may beconstructed to limit the amount of bending at the incision site. Thereinforcing features 225, 225′ in these embodiments may be stiffer thanthe skin S, and preferably stiffer than the surrounding elements of thebase panels 104, 106. In this way, and bending or compression of theskin S through normal patient motion would be isolated, or thepropagation limited, around the incision site. While this motionisolation or limitation would help strengthen the incision site intension, a greater benefit may be to prevent the incision edges fromsignificantly or unevenly inverting, everting, or shifting in adirection perpendicular to the skin surface. Reinforcing materialsdiscussed above may be used, with the thickness tailored to create thedesired stiffness. Preferably, the composite of the base assembly 102and cover 220 may be constructed to create a smooth transition instiffness and compliance from the surrounding skin to the isolatedincision site.

In particular methods of use, after initial closure of the incisionusing the base assembly 102 to approximate the skin edges, the basepanels 104, 106 may be pushed together further to “pooch” the closedincision I upward to slightly evert the edges and/or compress the skin Saround the incision edges to relieve tension. FIGS. 25A-25C illustratean embodiment of this method in an in-vivo tissue model. FIG. 25A showsa step 250A in which the base panels 104, 106 are adhered to the skin Sadjacent an incision I and are pushed together to “pooch” the closedincision I upward. The base panels 104, 106 may be then pulled togetherfurther to hold the tissue in this orientation. These methods may beenhanced by positioning the base panels 104, 106 away from the incisionedge by 5-10 mm. In a step 250B shown by FIG. 25B, the base panels 104,106 may be locked in place relative to one another with the straps 130and the locks 132. In a step 250C shown by FIG. 25C, the cover 220 maythen be applied to lock in the relative location of the base panels 104,106 and “pooched” incision I. The incision I could be further reinforcedwith the reinforcing elements 225, 225′ discussed above.

A given cover 220 may in many embodiments be fitted with release linersto aid in user handling of the cover 220 before and during applicationto the patient. As shown in FIGS. 22A and 22B, the cover 220 may haverelease liners 223 a, 223 b applied in a three-part configuration. Theuser may first remove a longitudinal center liner 223 b to apply thecenter exposed adhesive to the base assembly 102 and skin incisionregion. Removal of this liner 223 b first, in combination withvisualization through the clear plastic and/or openings in the center ofthe base 220, may allow the user to see the base assembly 102 underneathsuch that the cover 220 can be properly aligned with the base assembly102 as the cover 220 is applied. This may also help provide regions ofthe cover 220 that do not stick to the user until the cover 220 isinitially secured to the base assembly 102 and/or the skin S. Next, theside release liners 223 a may be removed in a direction perpendicular tothe incision I. The liners 223 a hold and tension the very thin urethaneto keep it from substantially wrinkling as it is applied to the skin S.Also, by sticking the center of the cover 220 to the base assembly 102and/or the skin S first, the cover 220 may be held in place such thatsufficient tension and control may be applied to the side release liners223 a for smooth application of the remainder of thin adhesive coatedcover 220 to the patient. Alternatively or in combination, the linersmay be constructed such that the first liner is removed to expose anarrow strip over the full width of the cover 220 (perpendicular to theincision I) to allow initial placement on the base assembly 102 and/orskin S, followed by removal of one or two additional liners in adirection parallel to the incision I. The first liner may be in themiddle of the length, on either end, or somewhere in between. If not onthe end, two additional liners may be required, each removed in adirection from the location of the first liner outward along the lengthof the device. If the first liner was on one end, a second single linermay be removed from the location of the first liner out toward the endof the device.

Another release liner configuration may be to have a single liner whichcould be completely removed from the bottom of the cover 220 beforeapplication. This type of liner may require an outer film, or castingsheet, be lightly adhered to the outer surface of the cover 220 to helpthe thin urethane hold its shape and provide the user with locations atthe sides and/or ends which do not have adhesive and thus would notstick to the user's hands during application. The outer film could beover the entire outer surface or just a particular width surrounding theperimeter of the cover 220. The film and/or the release liner could alsohave an area extending beyond that of the thin urethane in the cover220. Once the cover adhesive is attached to the base assembly 102 orskin S, the casting sheet may be easily removed from the outside of thecover 220.

As described herein, flexible wound dressings and wound or incisionclosure devices or appliances are typically flexible and stretchable tofollow the contour of curved parts of the body (e.g., arm, longerincisions that are curvilinear, etc.) or the areas that undergostretching (e.g., knee). To assist the draping of such devices, abacking material may be used which assists in maintaining the dressingshape during the application. Such temporary backing material describedherein may have a number of advantages. The backing material may beclear to enable the visual of the wound. The material may benon-stretchable to prevent elongation of the dressing or closure deviceor appliance during application. The backing may be easily removableafter the application of the wound dressing or closure device orappliance so as to not affect the adhesion of the actual dressing on thewound site. The backing material may also assist in the handling of thedressing during manufacturing process. In many embodiments, the backingmaterial may couple to a dressing or closure device with peel-offrelease liners on the adhesive side of the dressing to enable easy andreliable removal of the backing material.

Referring now to FIG. 26A, a wound dressing cover 2600 may comprise aflexible sheet 2610 made of a flexible material like rubber, urethane,silicone, etc. The flexible material 2610 may laminated on a relativelystiffer material in the form of a casting sheet or carrier layer 2620.The casting sheet 2620 prevents the flexible material 2610 from rollingonto itself and becoming unusable. The flexible sheet 2610 may have anadhesive on one side (e.g., the bottom side) and a relatively rigid(stiff) carrier layer or casting sheet 2620 on the other side. Theadhesive side is protected by two liners 2630, 2640 that can besequentially removed to expose the adhesive in a controlled manner. Toapply the dressing 2600 on the wound or incision, a small strip ofadhesive is exposed by removing one of the release liners, usually thesmaller release liner 2630. This release liner 2630 may be attached tothe casting sheet 2620 using a tape 2650. The exposed part of theflexible sheet 2610 may then be adhered at one end of the wound orincision. The flexible cover 2600 then follows the contour of the woundor incision and the curvature on the body as the second release liner2640 is slowly removed to expose the adhesive sequentially.

The first release liner 2630 which is typically still attached to thecasting sheet 2620 with the tape 2650 may then be used to lift thecasting sheet 2620 from the flexible dressing 2610.

A manufacturing process for the wound dressing cover 2600 and associatedliners 2630, 2640 may be to use a single die to cut a common profile(perimeter) of the laminate of the release liners 2630, 2640, theflexible dressing (with adhesive) 2610, and the casting sheet 2620. Uponremoval of the liners 2630, 2640 and application of the dressing sheet2610 to the skin, the casting sheet 2620 may remain on the dressingsheet 2610. Removal of the casting sheet 2620 may require initiation bydelaminating and peeling back an edge of the casting sheet 2620 from thedressing sheet 2610. Once initiated, the continued peel and removal ofthe casting sheet 2620 may be straightforward. Initiation and lift ofthe edge of the casting sheet 2620 may not always be intuitive and mayrequires a free edge connected to the casting sheet 2620 to helpidentify the lift point and begin the peel. The tape 2650 may be used tobridge the casting sheet 2620 to the release liner 2630 and may providean easily identifiable tab which can be used to initiate the peel.

Alternative configurations of the casting sheet 2620 may be used toinitiate the peel of the casting sheet 2620 as shown in FIGS. 26B-26E.

As shown in FIG. 26B, the casting sheet die may be cut such that thecasting sheet 2620 a extends axially beyond the flexible dressing sheet2610 (e.g., the liners 2630, 2640 and urethane material of the flexibledressing sheet 2610 may be “kiss cut” to the surface of the castingsheet 2620 a).

As shown in FIG. 26C, the casting sheet 2620 may have tape 2650 appliedto either one or both axial sides to extend beyond the casting sheet.The tape 2650 may not necessarily be attached to the release liner 2630.

As shown in FIG. 26D, casting sheet tape 2650 may be attached at or nearthe axial edge(s) of the casting sheet 2620 and also extends inside theprofile of the casting sheet 2620, with a loose non-adherent edge 2652for the user to grasp.

As shown in FIG. 26E, the casting sheet die may be cut (e.g., kiss cutsuch that the casting sheet 2620 is not cut into the flexible dressingsheet 2610) from one axial edge to a partial or full-length distance toanother axial edge of the casting sheet 2620. The cut casting sheet 2620may be separated with a “pinch” by the user to create an edge to grasp.The interior die cut edge may also have a tape or similar tab 2654applied to one or both of the interior edges to grasp and peel as shownin FIG. 26E.

In many embodiments, the casting sheet 2620, 2620 a and/or tape 2650,2652, 2654 may be of a different color or have markings to distinguishfrom the flexible dressing sheet 2610 and release liners 2630, 2640.

One or more of the components of the incision closure appliances orincision closure appliance assemblies disclosed herein, including one ormore of the various base assemblies, base panels, force distributionstructures, axial supports, lateral supports, closure components, tieassemblies, straps, locks, adhesive layers, adhesive layers, covers,cover structures, drapes, etc., may be comprised of, be coated with, orotherwise incorporate one or more of an antifungal, antibacterial,antimicrobial, antiseptic, or medicated material. For example, suchmaterials may be incorporated into the hydrocolloid adhesive layer, asanother layer or coating between the skin and the adhesive layer(covering at least a portion of the adhesive layer), incorporated intothe base assembly cover or at least its adhesive layer, etc. One or morewells, grooves, openings, pores, or similar structures may be providedon the device or apparatus components to facilitate such incorporation.In many embodiments, such materials may comprise one or more of silver,iodide, zinc, chlorine, copper, or natural materials such as tea treeoil as the active agent. Examples of such antifungal, antibacterial,antimicrobial, antiseptic, or medicated materials include, but are notlimited to, the Acticoat™ family of materials available from Smith &Nephew plc of the U.K., the Acticoat® Moisture Control family ofmaterials available from Smith & Nephew plc of the U.K., the Contreet®Foam family of materials available from Coloplast A/S of Denmark, theUrgoCell® Silver family of materials available from Urgo Limited of theU.K. (a subsidiary of Laboratoires URGO of France), the Contreet®Hydrocolloid family of materials available from Smith & Nephew plc ofthe U.K., the Aquacel® Ag family of materials available from ConvaTecInc. of Skillman, N.J., the Silvercel® family of materials availablefrom Kinetic Concepts, Inc. of San Antonio, Tex., Actisorb® Silver 220available from Kinetic Concepts, Inc. of San Antonio, Tex., the Urgotul®SSD family of materials available from Urgo Limited of the U.K. (asubsidiary of Laboratoires URGO of France), the Inadine® family ofmaterials available from Kinetic Concepts, Inc. of San Antonio, Tex.,the Iodoflex® family of materials available from Smith & Nephew plc ofthe U.K., the Sorbsan Silver™ family of materials available from AspenMedical Europe Ltd. of the U.K., the Polymem Silver® family of materialsavailable from Ferris Mfg. Corp. of Burr Ridge, Ill., the Promogram™family of materials available from Kinetic Concepts, Inc. of SanAntonio, Tex., the Promogram Prisma™ family of materials available fromKinetic Concepts, Inc. of San Antonio, Tex., and the Arglaes® family ofmaterials available from Medline Industries, Inc. of Mundelein, Ill..Components of the closure devices described in commonly owned U.S. Pat.Nos. 8,313,508, 8,323,313, and 8,439,945; U.S. Patent Publication No.2013/0066365; and PCT application nos. US 2010/000430, US 2011/139912,US 2011/40213, US 2011/34649, and US 2013/067024 may also be comprisedof, be coated with, or otherwise incorporate one or more of anantifungal, antibacterial, antimicrobial, antiseptic, or medicatedmaterial, including but not limited to one or more of the materialslisted above.

In many embodiments, topical medicinal agents are incorporated directlyinto the wound closure appliances described herein. Because a woundclosure device is often applied in close proximity to a wound orincision in need of medicinal protection, the incorporation of suchmedicines directly into the closure device may be beneficial. In woundsat risk of infection, incorporation of anti-microbial agents may bebeneficial, for example. Anti-microbial agents may include antibioticmedicines as well as antiseptic metal ions and associated compoundswhich may include silver, iodine, copper, and chlorine, or naturalmaterials such as tea tree oil. In wounds prone to fungus, medicinalagents such as zinc may be warranted, for example. Combinations of anyof these agents may also be of benefit and thus may be incorporated intowound closure appliances.

Topical medicinal agents may be incorporated into the closure devices ina way to give the closure devices the ability to wick exudate away fromthe wound (e.g., to direct unwanted organisms away from the wound and/orprevent skin maceration), while keeping the wound sufficiently hydratedfor improved healing.

Referring now to FIG. 27A, a wound or incision closure appliance 2700comprises a base comprising two base panels 2710R, 2710L comprisingupper polymer layers 2720R, 2720L and lower adhesive layers 2730R, 2730Lapplied in close proximity to each side of a surgical incision I.Features of the panels 2710R, 2710L, such as straps 2740, may allow theskin on either side of the incision I to be drawn together and held inplace during the healing period. The adhesive may preferably comprise ahydrocolloid formulation, but may comprise acrylic or other adhesivesknown in the art. The upper polymer layers 2710R, 2710L (e.g., 1 milpolyurethane) are preferably applied to the top of the adhesive layers2720R, 2720L to isolate the adhesive layers 2720R, 2720L. Medicinalagents may be incorporated into the structure of the base panels 2710R,2710L. At a minimum, the agents may inhibit growth of unwanted organismswhere they contact the skin from the base panes 2710R, 2710L. The agentsmay be released from the base panels 2710R, 2710L and may migrate toregions within or in close proximity to the wound. The agents may becontained with carrier structures, such as adhesive layers 2730R, 2730L,which are able to absorb fluid and aid in the release of the agents.Such structures may include hydrocolloids, hydrofibers (such as thosecontaining sodium carbomethylcellulose), hydrogels, collagen, alginates,foams of polyurethane or silicone, or other related materials known inthe art. The carrier could alternatively or in combination be anointment, cream, gel, or powder. The medicinal agent (such as silverions) may alternatively or in combination be applied to metals orpolymers (for example, in mesh form) via a solvent coating process orvapor deposition. Such mesh-like products may be bonded or imbedded inthe structure of a closure device.

In exemplary embodiments, a medicinal agent comprising a silver compoundsuch as silver sulfate may be incorporated into the base panels 2710R,2710L. As the base panels 2710R, 2710L come into contact with woundexudate and/or sweat or external fluids, the agents may be carriedtoward the wound. As fluid is absorbed into the base panels 2710R,2710L, the base panels 2710R, 2710L may be able to release the silverions which interfere with bacterial growth. Examples of how an agentsuch as silver may be incorporated into the base panels are shown inFIGS. 28A-28B, which show various embodiments of sample segment 2750 ofthe right base panel 2710R in FIG. 27. These examples may also apply forthe left base panel 2710L.

FIG. 27B shows a medicinal agent 2760R blended directly into theadhesive layer 2730R in the sample segment 2750. The adhesive istypically a hydrocollid, which may be able to absorb a significantpercent of its weight in fluid, thereby aiding the release of theagents.

FIG. 27C shows another embodiment of the sample segment 2750 of the basepanel 2710R in which the medicinal agent is incorporated into a carrierstructure 2770R which is incorporated on top of the base panel 2710R,preferably concentrated on the part of the base panel 271OR near theincision I. Further features may be incorporated to strip away (andreplace as needed) the carrier structure 2770R if it becomes saturatedwith exudate or other fluids, and/or the concentration of the medicinalagent drops below and effective level.

FIG. 27D shows an embodiment similar to that of FIG. 27C in which thecarrier structure 2770R comprising the medicinal agent is incorporatedon the inside edge of the base panel 2710R.

FIG. 27E illustrates how the carrier 2770R could be incorporated ontoboth the top and inside edge of the base panel 2710R. In these examples,the carrier structure 2770R on either or each inside edge of the basepanel 2710R may be compressed over the wound or incision I to aid in itsstability over the wound or incision I.

Medicinal agents and their carrier structures may alternatively or incombination be incorporated into the cover for the incision closureappliance. As described above, the cover is typically applied over thebase panels of the incision closure appliances to help secure theappliance to the skin and protect the skin. As shown in FIG. 28A, acover 2800 could have the medicinal agent 2810 incorporated into theentire surface of the cover 2800 with or without a carrier structure,such as adhesive layer 2810 mixed with the medicinal agent.Alternatively or in combination, the agent may be incorporated into adiscreet portion of the cover 2800, preferably within a carrierstructure 2820 lying directly over the wound site as shown in FIG. 28B.

In at least some instances, the carrier structure 2820 may becomesaturated over time and/or lose its medicinal strength, and replacingthe medicinal structure 2820 will be of benefit. As shown in FIG. 28C,the medicinal structure 2820 could be removable (e.g., through tear-awayperforations 2830 in the cover 2800) and optionally replaced withanother medicinal structure 2821 coupled to the narrow cover strip 2801shown in FIG. 28D. In the narrow cover strip 2801, the adhesive portionof the cover 2801 may extend beyond the medicinal structure 2821 to holdthe structure 2821 against the skin. The narrow strip 2801 mayalternatively be applied to the wound site before the cover 2800 isapplied. The cover 2800 may be designed to cover the narrow strip 2801,or the may have perforations 2830 to allow removal of the underlyingstrip.

For either or both the base panels 2710R, 2710L and the cover 2800, thecarrier structures 2770R or 2820 (with or without the medicinal agent),or the medicinal agent alone, could be patterned with the adhesive layerof the respective structure. A patterned construction may comprise arepeating shape (e.g., circles, ovals, polygon, slots, etc.) of adhesivematerial adjacent a similar repeating shape (or remainder of the matrix)of the carrier structure. This would help ensure adhesion of the basepanels 2710R, 2710L or cover 2800 while integrating the medicinal agentwithin the carrier structure 2770R or 2820. A simple example is shown inFIG. 29E in which the carrier structure 2820 comprises a repeating shape2850. The medicinal agent and carrier structure 2820 could also beapplied to the base straps 2740 which cross the incision I.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An incision closure apparatus comprising: a firstbase panel for being adhered to a first side of an incision or wound,the first base panel comprising an upper surface and a tissue adherentlower surface; a second base panel for being adhered to a second side ofthe incision or wound opposite the first side, the second base panelcomprising an upper surface and a tissue adherent lower surface; and aplurality of lateral ties coupling the first and second base panels toone another, wherein the lateral ties each have one end fixed to thefirst base panel and a second end reversibly and adjustably attached tothe second base panel, thereby allowing the lateral ties to draw thefirst and second base panels together to compress the wound or incisioncovered by the incision closure apparatus, and wherein the lateral tiesare each reversibly and adjustably attached to the second base panelsuch that a spacing between the first and second base panels isadjustable.
 2. The incision closure apparatus of claim 1, wherein theopposite end of each lateral tie is disengagable and re-engagable fromthe second support.
 3. The incision closure apparatus of claim 1,wherein the lateral ties is independently adjustable to such that thespacing between the first and second panels is variable along the lengthof the first and second panels.
 4. The incision closure appliance ofclaim 1, wherein the second end of each lateral tie is releasablyattached to a lock, and wherein the lateral tie and lock together form aratchet tightening mechanism.
 5. The incision closure appliance of claim1, further comprising a first plurality of axially spaced-apart supportscoupled to the upper surface of the first base panel and a secondplurality of axially spaced-apart supports coupled to the upper surfaceof the second base panel.
 6. The incision closure appliance of claim 5,wherein one or more of the first or second plurality of axiallyspaced-apart supports comprise force distribution structures.
 7. Theincision closure apparatus of claim 5, wherein one or more supports ofthe first or second plurality of axially-spaced apart supports isdisposed laterally between inner and outer edges of the first or secondbase panel, respectively.
 8. The incision closure apparatus of claim 5,wherein the supports comprise flexible, non-distensible materials. 9.The incision closure apparatus of claim 5, wherein the supports areembedded in or laminated to the upper surface of each panel.
 10. Theincision closure apparatus of claim 5, wherein one or more of thesupports are C-shaped.
 11. The incision closure apparatus of claim 1,wherein one or more of the first or second base panels comprise anelastic matrix.
 12. The incision closure apparatus of claim 11, whereinthe elastic matrix comprises an elastomeric membrane, a woven fabric, aspun fabric, rubber, latex, urethane, polyurethane, silicone, or athermo plastic elastomer (TPE).
 13. The incision closure apparatus ofclaim 12, wherein the elastic matrix comprises a fabric woven fromelastic elements and having inelastic elements along lateral edges ofthe one or more of the first or second base panels and extendinglaterally thereacross.
 14. The incision closure apparatus of claim 1,wherein one or more of the first or second base panels comprise one ormore preferentially separating regions to facilitate one or more ofaxial separation or lateral stretching of the one or more of the firstor second base panels.
 15. The incision closure apparatus of claim 1,wherein the one or more preferentially separating regions comprise oneor more perforations.
 16. The incision closure apparatus of claim 15,wherein the one or more perforations are disposed axially betweenaxially adjacent supports on one or more of the first or second basepanels.
 17. The incision closure apparatus of claim 15, wherein the oneor more perforations comprise a plurality of perforations disposed alonga lateral line of the one or more of the first or second base panels.18. The incision closure apparatus of claim 15, wherein the one or moreperforations are disposed along a lateral edge of the one or more of thefirst or second base panels.
 19. The incision closure apparatus of claim1, wherein the tissue adherent lower surface of one or more of the firstor second base panels comprises a hydrophilic adhesive material.
 20. Theincision closure apparatus of claim 19, wherein the hydrophilic adhesivematerial comprises one or more of a hydrocolloid, a hydrogel, an acrylicpolymer, or poly(ethylene glycol).
 21. The incision closure apparatus ofclaim 1, further comprising a securing layer adapted to be placed overan assembly of the first and second base panels and the lateral tiesafter the assembly has been secured over the incision or wound.
 22. Theincision closure apparatus of claim 21, wherein the securing layer hasan inner self-adhesive surface.
 23. The incision closure apparatus ofclaim 21, wherein the securing layer is configured to laterally extendbeyond an outer lateral edge of the first or second base panel.
 24. Theincision closure apparatus of claim 21, wherein the securing layer hasone or more preferentially separating regions to allow the securinglayer to at least partially stretch axially in response to axialstretching of the incision or wound and surrounding tissue the incisionclosure appliance is placed over.
 25. The incision closure apparatus ofclaim 24, wherein the one or more preferentially separating regionscomprises one or more perforations.
 26. A method of closing a wound orincision, the method comprising: adhering a first base panel to a firstside of an incision or wound, the first base panel having a firstplurality of axially spaced-apart supports coupled to an upper surfacethereof; adhering a second base panel to a second side of the incisionor wound, the second base panel having a second plurality of axiallyspaced-apart supports coupled to an upper surface thereof; and couplingthe first and second base panels together with a plurality of lateralties, wherein the lateral ties each have one end fixed to the first orsecond base panel, and wherein coupling the first and second base panelstogether comprises reversibly and adjustably attaching the opposite endto the opposite base panel.
 27. The method of claim 26, furthercomprising disengaging and re-engaging the opposite end of a lateral tiefrom the support on the opposite base panel.
 28. The method of claim 26,further comprising independently adjusting the attachment of eachlateral tie to the second end to vary the spacing between the first andsecond panels along their lengths.
 29. The method of claim 26, furthercomprising placing a securing layer over the first and second panelsafter the first and second panels have been coupled to one another. 30.The method of claim 26, wherein the securing layer is configured tolaterally extend beyond an outer lateral edge of the first or secondbase panel.